NITRO Teaming Profiles
Thank you for showing an interest in ARPA-H’s Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) program. This page is designed to help facilitate connections between prospective proposers. If either you or your organization are interested in teaming, please submit your information via the form below. Your details will then be added to the list below, which is publicly available.
NITRO anticipates that teaming will be necessary to achieve the goals of the program. Prospective performers are encouraged (but not required) to form teams with varied technical expertise to submit a proposal to the NITRO BAA.
Please note that by publishing the teaming profiles list, ARPA-H is not endorsing, sponsoring, or otherwise evaluating the qualifications of the individuals or organizations included here. Submissions to the teaming profiles list are reviewed and updated periodically.
Interested in learning more about the NITRO program?
- Read the NITRO Broad Agency Announcement.
- Register to attend the hybrid Proposers’ Day on June 15, 2023 (Closed).
- NITRO program overview page.
Teaming Profiles List
To narrow the results in the Teaming Profiles List, please use the input below to filter results based on your search term. The list will filter as you type.
| Organization | Contact Information | Location | Focus Area(s) | Strengths/Experience | Reason(s) for Partnering | Technical Area(s) | Offer NITRO and/or Partners |
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| Texas A&M Unniversity | Akhilesh Gaharwar (gaharwar@tamu.edu) | College Station, TX | Our organization's current research focuses primarily on developing innovative nanotherapies for osteoarthritis. We've introduced a novel mineral-based therapy, CartiRevive, which promotes in situ cartilage regeneration, targeting the root cause of osteoarthritis instead of just managing symptoms. This involves using mineral-based nanoparticles to stimulate the growth of cartilage cells and adjoining mesenchymal stem cells, enhancing the production of cartilaginous extracellular matrix. Additionally, we are addressing limitations in late-stage osteoarthritis treatments through our advanced technology, CartiRenew. It is specifically designed for advanced osteoarthritis stages and leverages mineral-based nanotherapy for the sustained, localized release of immunotherapy and reprogramming factors. Its unique characteristics allow for extended retention within the joint space, ensuring a prolonged therapeutic effect. By providing a solution to these critical challenges, we hope to improve treatment efficacy in advanced osteoarthritis stages significantly. |
Our organization excels in the design, development, and optimization of injectable biomaterials tailored for minimally invasive delivery. This strength enables us to create and refine solutions that maximize therapeutic effectiveness while minimizing patient discomfort and recovery time. In addition to this, we possess robust expertise in understanding the impact of biomaterials on the transcriptomic and epigenetic landscape. This deeper understanding allows us to fine-tune the biomaterials' interactions with biological systems, ensuring optimal compatibility and efficacy. Our years of experience in these areas have equipped us with the skills and knowledge necessary to innovate and lead in the realm of biomaterials science. | Our organization is seeking potential teaming partners with the capability and expertise to evaluate our technology under in vivo models. This includes both small and large animal testing environments. The ideal partner would have a proven track record in the successful execution of animal model studies, with deep understanding of the associated regulatory requirements. The ability to effectively translate findings from these studies into actionable insights will also be key. Ultimately, we aim to collaborate with teams that share our commitment to rigorous testing and the advancement of bioengineering technologies. |
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Our organization can offer NITRO and potential teaming partners a wealth of bioengineering expertise, particularly in the realm of bone and cartilage regeneration. We bring to the table our proprietary mineral-based technologies capable of stimulating these regenerative processes. Our strong proficiency in injectable hydrogels, self-healing biomaterials, and bioactive nanomaterials facilitates advanced tissue restoration. Additionally, we offer an advanced understanding of sustained therapeutic protein delivery, enabling prolonged therapeutic action. This unique combination of skills and knowledge places us in a prime position to contribute to multifaceted bioengineering projects. |
| SignaBlok, Inc. | Alexander B. Sigalov (sigalov@signablok.com) Additional: info@signablok.com |
Shrewsbury, MA | SignaBlok has an expanding, deep and diversified pipeline of new chemical entity (NCE) assets leveraging SignaBlok's proprietary technologies to shape macrophage biology in multiple inflammation-associated diseases and disorders where macrophages are centrally involved. Our current research focus include cancer, autoimmune, retinopathy, and other inflammatory diseases and conditions. Example is osteoarthritis (OA). | We developed the concept of ligand-independent inhibition of cell receptors. We also developed a nature-inspired approach to targeted delivery of such inhibitors. We have a strong experience in rational design of TREM-1 and TREM-2 inhibitory peptides, preparation and characterization of their good manufacturing practice (GMP)-friendly nanoparticulate formulations. We also have an experience and expertise in collaborative work with academia and contract research organizations (CROs) on animal proof-of-concept work. Our nanoparticulate TREM-1 inhibitory formulations were recently recognized by the Nanotechnology Characterization Laboratory (NCL) at NIH as one of the most promising therapeutic nanoformulations. | We are looking for collaborative development of our TREM-1 and/or TREM-2 inhibitors as drug candidates for the treatment of OA. As mostly NIH-funded company, we are also interested in raising funding for this project. |
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Macrophages are key inflammatory cells that play role in pathogenesis of all types of arthritis including rheumatoid arthritis and OA, which also manifest as a result of post-traumatic OA (PTOA). TREM-1 and TREM-2 receptors, inflammation amplifiers, are overexpressed on macrophages upon inflammation and amplify systemic and local inflammatory responses. We developed macrophage-targeted TREM-1 and TREM-2 peptide inhibitors that employ a novel, ligand-independent mechanism of receptor inhibition. For TREM-1 and TREM-2 receptors, this mechanisms of action is especially important and advantageous because TREM-1 and TREM-2 ligands are still unknown. SignaBlok's TREM-1 and TREM-2 blockers prevent and treat arthritis in preventive and established collagen-induced arthritis mouse models. We propose to advance regenerative and reconstructive strategies for treating OA, using these innovative TREM-1 and TREM-2 approaches to enable revolutionary advances in patient care algorithms. |
| Weinberg Medical Physics, Inc. | Irving Weinberg MD PhD (inweinberg@gmail.com) | Rockville, MD | We are an incubator focusing on applications of medical imaging and image-guided therapy. | We have built products used by millions of people. We have started companies in multiple states and countries, that now have commercial medical and veterinary products. | We are looking for drugs, genes, and scaffold materials that could be delivered, and partners for animal (and eventual human) testing. Our job will be to get those substances where they need to be in the joint. |
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We have built compact devices that use magnets to both collect high resolution MR images as well as manipulate magnetic particles in real-time. The magnetic particles can deliver drugs and genes through cartilage and into bone, and create scaffolds (as 3-D in site printers) with bio-degradable materials or iron-loaded cells. |
| University of Iowa | Elisabeth Buettner (Elisabeth-Buettner@uiowa.edu) | Iowa City, IA | Biomechanics | ||||
| Stanford University | Heike E. Daldrup-Link, MD, PhD (heiked@stanford.edu) Additional: vidyani@stanford.edu |
Stanford, CA | We have established a large animal model for matrix associated stem cell implants and chondrocyte implants (MASI and MACI) in arthritic joints of pigs. We are developing clinical-translational medical imaging techniques that allow us to longitudinally study the regeneration potential of different cell therapies under various conditions with cell targeted biomarkers. I (PI) worked on this over the past 10 years via NIAMS 5R01AR054458 and UG3CA268112. | Strength: - experienced team with multi-disciplinary expertise - large animal model of MASI and MACI, established over the past ten years - cutting edge medical imaging techniques, arguably more advanced than anywhere else - experience in multi-center collaborations |
Academic and Industry partners who would be interested testing new drugs or interventions that can improve the outcome of MASI and MACI - Academic and Industry partners developing senolytic therapies. |
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We have established high resolution MRI and PET/MRI imaging techniques that can visualize cell implants in arthritis joints, macrophage responses, differentiate viable and apoptotic cells and detect senescent cells. We can provide early biomarkers for success or failure of MASI or MACI which can be correlated with MOCART scores and histological outcomes. For example, we labeled mesenchymal stromal cells with clinically approved nanoparticles and monitored their integration into the joint. We found improved cell engraftment when we pre-treat MSC with ascorbic acid. We have developed clinical-translational biomarkers for cell senescence which are injected intra-articularly or intravenously, retained in senescent cells and provide a signal on PET scans, which can be quantified and monitored before and after senolytic therapies. |
| Rhode Island Hospital | Dr. Chathuraka T. Jayasuriya (chathuraka_jayasuriya@brown.edu) Additional: mmarshall6@lifespan.org |
Providence, RI | Our primary research focus is on musculoskeletal tissue engineering with particular interests in regenerative cell-based medicine, joint preservation, joint kinematics, and investigating the biological mechanisms of joint tissue healing and disease. | Our research team in Rhode Island Hospital consists of a strong multidisciplinary team of cell & molecular biologists, bioengineers, clinicians, and biostatisticians with a proven track record in improving musculoskeletal soft tissue (meniscus) repair and attenuating post-traumatic osteoarthritis (PTOA) in pre-clinical animal models. | Academia partners that have expertise to test pain outcomes using neurological (nerve/receptor) analysis - Industry partners that have facilities and expertise to scale up manufacturing. |
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We offer expertise on orthopaedic joint tissue injuries and degenerative joint disease, as many of our investigators are experts in these fields. We have proprietary cell-based technologies that have shown efficacy in accelerating cartilage and musculoskeletal soft tissue repair. Lastly, we are located at a biomedical epicenter and can offer research lab space and the capacity to house pre-clinical small (and large) animal models with built-in MRI and Gait acquisition capabilities. |
| NANOCHON | Ben Holmes (ben.holmes@nanochon.com) Additional: nathan.castro@nanochon.com |
Washington, DC | Our focus is to deliver highly-effective, off-the-shelf solutions that allow sports medicine physicians help their patients return to the activities that they love. Nanochon’s Chondrograft™ replaces lost or damaged cartilage and encourages new growth using innovative material and 3D printed designs. | We are experts in tissue engineering, material science, advanced manufacturing, pre-clinical models, design and testing, and process/compliance. We also have deep clinical knowledge of challenges in joint health, cartilage restoration, and arthritis. | We are seeking clinical collaborators, co-developers for additional indications and uses of our technology, and funding. |
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Nanochon can offer a promising technology that is prime for clinical development in the joint health space, offering substantial improvements for both clinical outcome and implementation/access. |
| Skeletal Biology Section, NIDCR, NIH | Pamela Gehron Robey (pamela.robey@nih.gov) | Bethesda, MD | The Skeletal Biology Section in NIDCR focuses on determining the biological nature of stem cells that form skeletal tissues, the role that these cells play in skeletal diseases, and in particular, on how they can be utilized in skeletal tissue regeneration. We have developed preclinical animal models to evaluate bone regeneration by bone marrow stromal cells/skeletal stem cells in cranial critical sized defects in rodents and dogs, and more recently, we are working on developing a model of jawbone repair in rats. In addition, we have identified a scaffold that supports the formation of stable, non-hypertrophic cartilage by bone marrow stromal cells/skeletal stem cells. Other current areas are focused on differentiation of human induced pluripotent stem cells into bone derived from different embryonic origins (i.e., paraxial and lateral plate mesoderm, and neural crest), and into stable, non-hypertrophic cartilage. | Skeletal Biology Section in NIDCR has 30+ years of experience in determining the biological nature of stem cells that form skeletal tissues, the role that they play in skeletal diseases, and how they can be utilized in tissue engineering. We have extensive expertise in utilizing human bone marrow stromal cells/skeletal stem cells (BMSCs/SSCs) for formation of bone and cartilage in vivo. This has required the development of optimal ex vivo expansion protocols, identification of appropriate scaffolds to support bone or cartilage differentiation, and development of appropriate animal models for in vivo testing. The section, in collaboration with the Cell Processing Section in the NIH CC, developed a Drug Master File for generation of GLP-grade BMSCs/SSCs along with 3 INDs that were used in NIH IRB-approved clinical trials (but not for bone or cartilage regeneration). In addition, we have concocted methods for the differentiation of human induced pluripotent stem cells into bona fide bone and cartilage, based on the outcomes of in vivo transplantation. The NIDCR has numerous core facilities for these types of studies including the Combined Technical Research Core (FACS and cell sorting), Imaging Core, microCT facility, and an advanced skeletal histology facility. | Based on our results to date, we feel that there is a real need to refine the scaffolds that are currently being using for both bone and cartilage regeneration. However, we are not biomaterial engineers and interactions with those who are, would go a long way to improve tissue repair of bone and cartilage. In addition, we lack the surgical expertise and the required resources to actually use our cell populations in well-designed clinical trials to treat human patients. |
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We in the Skeletal Biology Section have extensive knowledge in the development of the skeleton and skeletal stem cells in different locales. We have developed methods of generating bona fide bone and cartilage from adult human bone marrow stromal cells/skeletal stem cells and induced pluripotent stem cells based on a very solid understanding of developmental biology. These studies are based on in vivo transplantation assays, which are the gold standard by which to judge formation of bone and cartilage. Based on our activities, we feel that we can contribute significantly to Technical area 3 (Allogeneic, Autogenous, Non-Immunogenic, Osteochondroinductive, and Load Bearing Total Replacement Joints) of NITRO. |
| Wake Forest Institute for Regenerative Medicine (WFIRM) | Bill Vaughan (jvaughan@wakehealth.edu) | Winston Salem, NC | Although our residing institution has a broad interest in the regenerative medicine space, our group has a primary focus in musculoskeletal problems, including spinal cord injury. Gustavo Moviglia (MD PhD) and Gary Poehling (MD) are the chief scientist and overseeing clinician within our group, respectively. Dr. Moviglia, developer of our cell therapy, has a clinic in his native Argentina where he piloted this OA therapy in a phase 1 trial. Dr. Poehling is helping with production of our IND to the FDA an starting to organize the clinical support for the trial to follow. Since arriving at WFIRM, Dr. Moviglia and colleagues have shepherded several important animal experiments that have confirmed the therapy's capacity for recapitulating articular cartilage with hyaline-like (i.e. collagen II) characteristics. We are currently attempting to replicate these results within a primate model while also completing work on the tumor/tox studies needed to finalize the IND. | Gustavo Moviglia (MD/PhD) is an Associate Professor in the Regen. Med. Department at the Wake Forrest School of Medicine. 40+ years of experience in cell biology, cancer biology, and histology. Runs an innovative cell therapy clinic in his native Argentina, specializing in spinal cord injury treatment. Gary Poehling (MD) is a Professor of Orthopedic Surgery, former founder and Editor in Chief of the journal Arthroscopy. Although he has retired from the OR is still runs orthopedic clinics and plays a significant role in consulting and tutoring attending and budding new students in the Orthopedic Department at Wake Forrest. Lawrence Webb (MD) is a Professor of Orthopedic Trauma at the Wake Forrest School of Medicine. He currently runs clinics at the medical center and at satellite clinics located throughout Western North Carolina. William Wagner (PhD) is a Professor Emeritus in Plastic Surgeon and Reconstructive Surgery. He has expertise in material science, biomedical Engineering, nutrition, and cardiovascular disease. Johanna Bolander (PhD) is a Junior Professor at Charité Universitätsmedizin Berlin Institute of Health, specializing in the development of regenerative therapies focused on musculoskeletal tissues. Carlos Kengla (PhD) is an Assistant Professor of Biomedical Engineering with as focus on bone and cartilage. Bill Vaughan (PhD) Assistant Professor with a focus on Neurobiology |
We will be seeking to possible collaborations with tissue engineering groups that could assist with the development of a biologic prosthesis. |
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We have an autologous cell therapy that has the potential for changing the current standards in OA. treatments. We have shown that this therapy not only halts the progression of degeneration in OA, but can also reverse that process by adding new cartilage, improving irrigation of the subchondral bone, and immune modulating the joint in favor of normative tissue regeneration. As a mainline therapy for mild to moderate OA, we think this therapy by itself is sufficient to provide a suitable replacement for current approaches that mainly focus on pain reduction. However, we believe that these cells with the right extracellular matrix could provide an essential component for producing an engineered biologic prosthetic to replace the current suite of mechanical prosthetics currently in use. We would be interested in possibly collaborating with bio-engineers organizations for assisting with engineering side of this problem. |
| Arthroba | Samer Mabrouk (samer@arthroba.com) Additional: tommy@arthroba.com |
Atlanta, GA | Wearable medical devices to track changes in the knee joint physiology, kinetics and kinematics for patients receiving knee PRP injections. | Our technolgy stemmed from Georgia Tech through DARPA funding. Our technology has shown great efficacy in tracking rheumatoid arthritis disease activity in patients receiving ultrashound therapy for RA. Our team also consists of orthopedic surgeons, biomechanics expert and rheumatologist. | Our organization is looking for teams than can better utilize our technology to predict and improve treatment outcomes. We are also looking for partners that can help us build a larger dataset to improve our diagnostic and predictive algorithms. |
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Our organization can offer objective metrics to track longitudinal outcomes of theraputics and better understand their mechanism of action, instead of relying on subjective info from patients. |
| Washington University School of Medicine | Audrey McAlinden (mcalindena@wustl.edu) | St Louis, MO | RNA targeting approaches to treat skeletal conditions including osteoarthritis, heterotypic ossification and bone fracture. Specific focus on microRNAs and siRNAs. | Strengths and experience in: 1) microRNAs and lentiviral approaches to modulate their expression in vitro and in vivo, 2) utilizing skeletal progenitor cells in chondrogenesis and osteogenesis assays in vitro; 3) mouse models of osteoarthritis, ulnar fracture repair, heterotopic ossification; 4) immunostaining and biochemical approaches to assess cartilage extracellular matrix production. | Expertise in: 1) methods for intra-articular delivery of RNA; 2) bone regeneration assays; 3) designing large-scale screening approaches to determine genes/proteins/compounds with cartilage/bone regenerative capacity. *Note: My laboratory is currently collaborating with Dr. Hua Pan at Washington University (peptide-based nanoparticle approaches for RNA delivery) |
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Expertise in: 1) mouse models of osteoarthritis, 2) conditional mouse models to study genes/proteins in cartilage and bone tissue; 3) in vitro assays (osteogenesis, chondrogenesis, cartilage explant cultures of human osteoarthritic knee joint specimens); 3) microRNAs; 4) immuno/biochemical assessment of cartilage extracellular matrix composition. |
| University of Oregon | Danielle Benoit (dbenoit@uoregon.edu) helenes@uoregon.edu |
Eugene, OR | Developing therapeutic approaches (cell & drug delivery) to treat osteoarthritis and models of osteoarthritis for in vitro develop of these approaches. | Regenerative medicine, including clinical translation, in musculoskeletal applications; unique in vitro development platforms, material technologies for cell and drug delivery | Large animal models to hasten translation. |
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In vitro OA models formed with diverse patient samples; In vivo OA models; drug/cell delivery strategies (drugs - small molecules, nucleic acids). |
| Remedium Bio, Inc. | Frank Luppino (fluppino@remedium-bio.com) Additional: agoraltchouk@remedium-bio.com |
Needham, MA | Rheumatology, Endocrinology, and Neurology. Therapeutic focus is biologics / gene therapy. | Remedium's strength and experience are centered around regenerative medicine for rheumatology, endocrinology, and neurology as well as gene delivery using viral and non-viral vectors. Our team has developed, industrialized, and launched a number of blockbuster palliative OA therapies including Cingal, Monovisc, Hyalofast, and Orthovisc. In addition, our team has developed, industrialized, and launched a number of rheumatoid arthritis / autoimmune treatments including Kevzara, Benepali, and Dupixent. | We are looking for strategic partnerships with biotech and pharma companies to enable the advancement of our lead therapeutic candidates to the clinic. |
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Remedium is a leading innovator in regenerative medicine, with a focus on rheumatology / cartilage regeneration. We have extensive experience in viral and non-viral gene delivery, in vitro and in vivo assays, and product development. |
| University of Michigan | Ivo Dinov (statistics@umich.edu) | Ann Arbor, MI | The Statistics Online Computational Resource (SOCR) designs, validates and freely disseminates knowledge. SOCR invents, implements, confirms, and shares cutting-edge tools and end-to-end computational protocols for study design, mathematical modeling, probability inference, statistical computing, and artificial intelligence. Working with collaborators, these resources are applied in a wide range of applications from health discoveries to STEM education, technology-enhanced instruction, and predictive big data analytics. | Collectively, SOCR Investigators have over 100 years of developing novel scientific methods, designing research studies, implementing advanced algorithms, engineering effective visualization tools, conducting basic STEM science research, and leading transdisciplinary biomedical research. SOCR investigators have consulted on hundreds of R&D projects and have developed powerful end-to-end protocols for collection, management, modeling, interpretation, and analysis of multi-source, heterogeneous, time-varying, incongruent, and incomplete datasets. | SOCR is looking for ARPA-H investigators that have critical needs of quantitative expertise to model, interpret, analyze, interrogate, visualize, validate, and report on uncommon datasets that can’t be manipulated using traditional software and established analysis protocols. We are looking for clinical partners that have massive amounts of complex information that requires revolutionary techniques and radically different tools to extract actionable results from obfuscated information. For example, we seek partnerships with NITRO clinical research teams that collect high-dimensional imaging, complex clinical, deep-resolution whole genome sequences, and other phenotypic datasets. SOCR develops computational protocols to holistically analyze the data by modeling their native joint distribution. This is different from contemporary approaches that model independently each data type and then pool the inference at the end. Our approach is holistic, it’s applicable to both supervised and unsupervised AI learning, ensures scientific reproducibility, and ultimately leads to lasting and cost-effective results. |
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Contemporary scientific discovery rewards discoveries for their speed and presentaiton, rather than their quality and lasting impact. Over 70% of published scientific reports fail independent reproducibility tests and more than 50% of the scientists cannot replicate their own experiments (Nature, DOI: 10.1038/533452a). This significant crisis of reproducibility of highly-funded scholarly work requires a new approach, novel incentives, and collective efforts to increase the return on investment of our limited resources. SOCR will offer a platform to engage all stakeholders in setting the foundational guidepost principles for collective validation, independent reproducibility, and confirmatory scientific reporting of all new ARPA-H discoveries. |
| Queensland University of Technology | Dr Indira Prasadam (i.prasadam@qut.edu.au) Additional: raymond.johnson@qut.edu.au |
Brisbane, Queensland, Australia | Our research is at the intersection of cell and gene therapies. We’re finding ways to regenerate damaged or dysfunctional tissue, repair cartilage defects. Our research focuses on developing effective therapies using three key technology streams: Cell-based and Cell free approaches We are optimising therapy solutions that use stem cell and primary cell populations to repair cartilage tissues and also exploring the role of extra cellular vesicles derived from the stem cells and their ability to repair the cartilage. Biomaterial approaches We are developing 3D printing, additive manufacturing and hydrogel technologies to create scaffolds that support tissue repair, medical devices and high-resolution cultures designed to examine cell-to-cell interactions or screen drugs. Cell and gene therapy We are developing or applying gene editing technologies to increase the potency of cell therapies and coupling these technologies with recognised cell stem therapies. |
We are experts in preclinical OA animal models, spatial imaging, advanced histology techniques, molecular work and and clinical trails. | While it is acknowledged that cell therapies hold great promise for providing effective repair of cartilage defects and OA, at this time no cell therapy procedures have been proven safe and effective through clinical trial, nor have they been granted regulatory approval. Cartilage degeneration induces a pro-inflammatory environment, which reduces cell anabolic activity and promotes the adoption of pathological catabolic and senescent cell phenotypes, promoting further tissue degeneration and preventing repair. As a result, there is an urgent need for a solution that reduces joint inflammation during healing, restores tissue functionality by promoting anabolic processes, and prevents OA progression. Our previous studies suggest that extracellular vesicles (EVs) secreted from mesenchymal stromal cells (MSCs) carry biological factors implicated in the protection and regeneration of damaged cartilage tissues and supress the synovial inflammation. This project's ultimate goal is to create proprietary platform technologies of bioengineered EVs as a potential novel off-the-shelf effective therapeutic treatment for OA progression and pain reduction and optimize translational route towards safe and effective clinical development. We are looking for collaborators and partners interested in this concept. In particular expertise in bio-reactor scaling up of EVs, hydrogel based delivery of EVs and toxicity testing expertise. riti. |
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Dr Prasadam is a mid-career researcher and NHMRC investigator fellow and the programme head for stem cell and tissue engineering at QUT's Centre for Biomedical Technologies, as well as the group leader for Biomimetic technologies for cartilage regeneration and osteoarthritis. She has a well-established track record in the OA field, and she was crucial in establishing one of Australia's few facilities capable of performing world-class OA research using both clinical and preclinical models. Notably, she was instrumental in forging research collaborations between The Prince Charles Hospital and QUT. This collaboration is focused to conducting clinical investigations and clinical trials for OA research and has created a tissue collection of OA patients' knee/hip samples, synovium, and blood. At MERF/QUT, Dr. Prasadam developed standard techniques for analysing joint pain in rats developed cutting-edge spatial phenotyping of joint tissues, and it is this research capacity development and competence that is required to execute the proposed NITRO program initiative successfully. |
| Purdue University | Deva Chan (chand@purdue.edu) Additional: deva.chan.phd@gmail.com |
West Lafayette, IN | Chan Musculoskeletal Research and Innovation (MRI) Lab at Purdue University - Joint health and osteoarthritis, especially post-traumatic osteoarthritis. Musculoskeletal imaging, orthopedic biomechanics and mechanobiology, hyaluronan sciences. | Purdue has a top 5 engineering program in the US, with close connections to the Indiana University School of Medicine and membership in the Indiana CTSI. The Chan MRI Lab has expertise that spans engineering, biology, and translational medical science. Our key strength related to NITRO is our use of noninvasive imaging to evaluate changes in tissues, which can be used for longitudinal studies as a means of evaluating treatment efficacy, and access to animal models, including noninvasive ACL rupture model of post-traumatic osteoarthritis in mice. | We are looking for experts in tissue engineering and regenerative medicine, especially those with interest in modulating systemic and local inflammation. |
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Expertise in (1) musculoskeletal imaging, including noninvasive measurement of structure, composition, and mechanical behavior of cartilage and other soft connective tissues (i.e., MRI, CT); (2) preclinical models of post-traumatic osteoarthritis and associated multi-organ/systemic analyses and comparisons; (3) in vitro culture of synovial joint tissues and cell types, including mechanobiological investigations. |
| UNC Thurston Arthritis Research Center & NC State Comparative Medicine Institute | Richard F. Loeser, MD (richard_loeser@med.unc.edu) Additional: mbfisher@ncsu.edu |
Chapel Hill and Raleigh, NC | The Thurston Arthritis Research Center (TARC) has a longstanding interest in basic, translational, and clinical research in osteoarthritis. We have over 50 members from departments across the University of North Carolina as well as NC State University and Duke. Research spans studies in human joint tissue cells, genomics, drug discovery, small animal models of OA, phenotyping and precision medicine, epidemiology, and OA clinical trials. We are home to the longstanding Johnston County OA study and the Osteoarthritis Action Alliance. Our collaborative work with NC State University includes working with investigators in the Comparative Medicine Institute (CMI). The mission of CMI is to promote scientific discovery and facilitate its clinical application to achieve the goal of improving the health of animals and humans. Functional tissue engineering and regenerative medicine are a major focus area, with over 60 active faculty members. Research themes include scalable manufacturing of novel cell and scaffold-based therapeutics, large animal models for regenerative medicine, and predictive bioanalytical systems, with musculoskeletal tissues being one key area of clinical application. | UNC is ranked number #5 among public universities in research. The UNC SOM has over 50 outstanding core facilities that cover all aspects of basic and clinical research. Our School of Pharmacy and Gene Therapy Center are superb. We are one of the few organizations in the US with strengths in both basic and clinical research in OA. The Johnston County OA study, in its 30th year, has an extensive database and biorepository from over 5000 participants. The NC State College of Veterinary Medicine is consistently ranked in the top 3 veterinary schools in the US and has one of the biggest referral hospitals in the US. The Clinical Trials center is set up specifically to handle trials in large animals, with both equine and canine patient populations. The College of Engineering is ranked #12 among public universities. The Department of Biomedical Engineering spans UNC and NC State and is ranked #7 in BME departments within the U.S., with faculty members focused on translating regenerative medicine into clinical solutions. The CMI at NC State has a track record of supporting the development and translation of regenerative therapies that are at various stages of commercialization. |
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| O'Brien Lab, Stem Cell Institute, University of Minnesota | Timothy D. O'Brien (obrie004@umn.edu) Additional: ziem0052@umn.edu |
Minneapolis, MN | We are developing an injectable (IA or IV) exosome product for the treatment of osteoarthritis. This product is derived from culture medium of iPSC-derived multi-tissue organoids which are comprised mainly of human hyaline cartilage. Preliminary data for this product indicates both anti-inflammatory and chondro-regenerative activities. | We have extensive experience in stem cell culture, organoid generation, and preparation and characterization of cell culture medium-derived exosomes. Our group also has deep expertise in pathologic/histopathologic assessment of orthopedic diseases. | Since we do not yet have data concerning the ability of our exosome product in promoting regeneration of subchondral bone we may need to collaborate with a group having an agent with this capability. |
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We are developing a unique exosome product, that is essentially derived from embryonic-like human cartilage, and which is injectable, and which preliminary data indicates has both anti-inflammatory and regenerative properties. The University of Minnesota has state-of-the-art surgical and medical facilities for both small and large animal studies to facilitate development and execution of small or large animal models of OA. The Center for Magnetic Resonance Research at U of MN is a world-renowned center for MRI providing state-of-the-art facilities for monitoring the progress of OA therapeutic models. |
| SmartLabs | Dr. Seth Taylor (staylor@smartlabs.com) Additional: jlevine@smartlabs.com |
Boston, MA | "We focus on building and operating the industry’s most advanced lab platform that delivers labs that are ready for scientists and their instrumentation to move in and start research. Our focus is on pioneering new ways to construct, resource, and operate labs in support of all therapeutic modalities, medical devices, diagnostics, and research or production systems. Our dynamic labs accelerate GMP, animal studies, biology, and chemistry from discovery through clinical trials. We are the leader in creating completely dynamic labs that allow us to provision a space to specific research requirements in a few weeks. This positions us on the leading edge of IOT, automation, and software solutions in support of advancing the capabilities of a lab. |
SmartLabs opened its doors in 2015 and since then has supported the leading companies in Boston and San Francisco. Our strength is helping our clients to get research up and running in a matter of weeks, rather than months, enabling them to add additional capacity as needed on-the-fly, and providing key capabilities co-located in the same facility. SmartLabs’ operations teams are built around industry leaders who enable our clients to focus their resources on R&D. Our vivarium program is AAALAC-certified and offers state-of-the-art facilities. Our roster of clients includes start-ups that have raised ~20% of the total money raised in Boston, public companies with late-stage pipelines, and enterprise companies. including large pharma. We have supported R&D across all types of modalities, including a large percentage of clients developing leading edge cell and gene therapies. Our focus on quality includes a quality management system replicated by some of our clients, and our programs have passed multiple audits by large pharma. |
SmartLabs brings critical lab resources and programs that can support most ARPA-H programs. Our goal is to help partners rapidly translate program dollars into results that accomplish key goals and benefit Americans. To this end, we have a proven track record of helping these types of companies reduce upfront capital expenditures via elimination of delays in accessing labs. ARPA-H partners can also leverage SmartLabs to access the diverse biotech expertise ecosystems of Boston and San Francisco and can locate teams closer to potential large pharma and academic partners. SmartLabs can work with any of these potential partners and support them with labs that can dynamically evolve to address their needs. |
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SmartLabs provides enterprise-grade labs delivered as a service that can support the full value chain of drug development including research, animal studies, process development, and clean room production. We offer these capabilities co-located in the same facility to enable more rapid research cycles. All of our labs come with operations to allow research teams to focus on R&D. Our current footprint is located in Boston and San Francisco, two geographies that encompass ~70% of the NIH research spend, with plans to expand into Philadelphia and other geographies. We can support the NITRO program with ready to deploy labs that can be customized on the fly to support NITRO program research and development. This can overcame resource gaps that other partners may have in delivering the NITRO program goals and also accelerate timelines." |
| Syntr Health Technologies, Inc. | Ahmed Zobi (azobi@syntrtech.com) Additional: hsalas@syntrtech.com |
Irvine, CA | Syntr Health's innovative approach encompasses a systematic methodology for the point-of-care processing of adipose tissue, which activates the inherent progenitor populations that can then be rapidly deployed to promote tissue repair for degenerative conditions such as knee osteoarthritis and difficult-to-treat wounds. This system was developed with microscale fluid dynamics to optimize adipose tissue microsizing that falls under FDA's guidelines of minimal manipulation while maintaining over 85% cell viability, and upregulation of several regenerative cells showing a 3- to 5-fold increase in markers that present anti-inflammatory and tissue repair responses allowing for the best treatment modality for this disease. We have optimized the parameters within our device that lead to utmost possible upregulation, while maintaining high cell viability, in regenerative phenotypes including the universal stem cell marker CD34, as well as CD13, CD73, and CD146. The intra-articular injection of microsized fat tissue into the infrapatellar fat pad, for example, has shown that macrophages can polarize from M1 to M2 variants which release anti-inflammatory cytokines to prompt tissue repair and regeneration, as well as down-modulation of other chemokines directly involved in the progression of the disease. Microfat resists environmentally poor tissue culture conditions (serum-free) and is capable of long-term cytokine release. | Our organization was founded by three biomedical engineers with various specializations whose combined expertise have been intricate in the development of our FDA cleared SyntrFuge System. We have over 20 years of combined experience in engineering centrifugal microfluidics platforms, Newtonian and non-Newtonian fluid dynamics, medical device manufacturing and troubleshooting, as well as stem cell biology and non-enzymatic stromal vascular fraction applications and deployment research. We have successfully conducted two clinical trials using our product for the treatment of diabetic foot ulcers and facial fat atrophy, both of which have been successful. | Higher level expertise in cell biology and analysis for the development of a systemic approach that utilizes the regenerative cells found in adipose tissue that we process in our device. We are looking to partner with entities that are complementary to our efforts and have the expertise to address subchondral bone regeneration, who can understand modulation of degradation markers (catabolic) and synthesis markers (anabolic) in the knee joint for the prevention of disease progression. |
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Our team's capabilities range from specializations in micro and nanotechnology to additive and subtracting manufacturing with vast experience in 3D Modeling using CAD software. We have an IRB approval to conduct this study with 176 patients for the treatment of knee osteoarthritis using our device. We are well-versed in writing protocols for IRB approvals, and we have connections with local orthopedic hospitals and physicians to conduct clinical trials. Our research staff has extensive knowledge conducting in vitro studies related to cartilage regeneration using adipose-derived stem cells from microfat processed in our device. Additionally, we've garnered extensive knowledge in regulatory affairs as we have gone through the FDA clearance process for our product. We are incubated at University Lab Partners in Irvine, CA, where we have 24/7 access to wetlab space equipped with state-of-the-art testing equipment for cellular/molecular biology (Attune NxT flow cytometer, biosafety cabinets, cell counters, real-time PCR, plate reader), analytical equipment, various microscopes (inverted tissue culture, ECHO Revolve/Rebel), centrifuges, cold storage refrigerators/freezers, and other general lab equipment. |
| Theradaptive | Luis Alvarez (luis@theradaptive.com) Additional: david.stewart@theradaptive.com |
Frederick, MD | Theradaptive is a therapeutic delivery platform company with a portfolio of therapeutics that are deliverable as part of an implant. We have developed variants of osteogenic and chondrogenic recombinant proteins that be tethered to implants to produce bone and cartilage with anatomical precision. | Protein engineering therapeutics, materials science, 3D printing, preclinical and clinical execution, analytical characterization | Partners with implants that need a biologic component such as a recombinant protein that can induce chondrogenesis or osteogenesis. |
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We have developed variants of osteogenic and chondrogenic recombinant proteins that be tethered to implants to produce bone and cartilage with anatomical precision. We also have the capability to 3D print fully resorbable anatomical implants that can be loaded with our modified recombinant protein therapeutics to bring about full joint replacement. |
| GID BIO, Inc. | William Cimino, Ph.D. (cimino@gidbio.com) Additional: dale.tomrdle@gidbio.com |
Louisville, CO | 1. Musculoskeletal tissue regeneration for durable therapeutic benefits for osteoarthritic joints. 2. Clinical evaluation in human clinical trials (under IDE) for osteoarthritis. |
Fundamental science of tissue processing for cell isolation and separation with efficient yield, viability, and delivery. Application and use in controlled human clinical studies at Phase I, Phase II, and Phase III levels. | Partners with focus on fundamental physiologic research in musculoskeletal degenerative disease. |
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Tissue processing technology to isolate, separate, and concentrate targeted cell populations (non-hematopoietic) for therapeutic application, including at point-of-care. |
| Egaceutical Corporation | Joel Huizenga (jhuizenga@egaceutical.com) Additional: rhuizenga@RobertsonDX.com |
La Jolla, CA | Human Age Reversal therapy and therapy for reversal of the diseases of aging including Arthritis. | We have a group that started working on human age reversal in 2013. We have a patented therapy called EGA that we have demonstrated to be safe and effective in small human clinical trials. The therapy consists of a grouping of small metabalomic compounds that are endogenous to human cells, decrease with age, and switch the energy use of the cells from cellular growth and cellular division to cellular defense and repair. | We are looking for any group with complimentary skills and or technologies. We are also looking for financing to do human clinical trials for FDA approval for therapy indications for any of the diseases age aging including arthritis. |
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We have 3 years of human biological age reversal data demonstrating very safe and effective human age reversal therapy with surrogate age markers such as inflammaging cytokines markers, multiple DNA methylation clocks such as GRIM Age, as well as other physical measurements like grip strength. In our group of individuals studied were individuals with osteoarthritis, all of which significantly safely benefited from the EGA therapy. |
| Duke University | Benjamin Alman (ben.alman@duke.edu) Additional: ashley.n.jones@duke.edu |
Durham, NC | Duke has a comprehensive research focus, with strengths in fundamental basic science, engineering, and clinical translational research. Duke one of the largest biomedical research enterprises in the country with $1 billlion in sponsored research expenditures annually. Our research focus in orthopedics includes basic, translation, engineering, clinical trials, and implemention research. | We have strength in all aspects of research and clinical care, and in translating fundamental science to clinical outcomes. As a demonstration of our depth in research orthopedics, we had the greatest NIH funding of any orthopedic department in the US in 2022. | A strong partner to share in advice and resources in direction, implementation, and analysis of our work. Identifying additional partners and collaborators to rapidy bring advances to clinical care. |
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We have a comprehensive team of biologists, engineers, and clinicians who have extensive experience in regeneration, and a track record in brining new advances into clinical care. One of our strengths is our ability to cross disciplines in our pursuit of clinically significant goals. By teaming with otters, we will be able to strengthen each other so that our outcomes together will be greater than the sum of each of our individual endeavors. |
| Montana State University | Ron June (rjune@montana.edu) Additional: rjune@montana.edu |
Bozeman, MT | Our lab focuses on using metabolomic (and other 'omic) profiling to better understand chondrocyte mechanotransduction and osteoarthritis. | Substantial expertise in mass spectrometry and metabolomic profiling, along with experience in optimizing metabolite extractions from multiple musculoskeletal tissues, as well as tissue engineered constructs. | We are looking to provide quantitative analysis of metabolite precursors for cartilage and bone regeneration. This analysis can provide partners with useful data to optimize media formulations, culture conditions, and other parameters for successful tissue regeneration. |
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To regenerate cartilage, several metabolic precursors are needed. We can offer targeted metabolomic profiling for the purposes of maximizing production of metabolic precursors to key cartilage components. |
| Confluence Biomedical Innovation | Matthew Weinstock (Matt@confluencebiomedical.com) | San Jose, CA | Autologous cellular injections | Clinical experience distributing a number of commercial FDA approved systems. We can facilitate commercialization of intellectual property | Technical expertise | Expertise and network of physicians currently in the clinical practice of interventional orthopedics using autologous biologics | |
| Dharma Bioscience | Gastón Topol (gtopol@hotmail.com) Additional: proloterapiaargentina@gmail.com |
Rosario, Argentina | Dharma Bioscience is an early-stage biotechnology company focused on the research and development of miRNA-based therapeutic products for degenerative articular diseases. | Our team is composed of experienced scientists and clinicians with a proven track record. We have a strong understanding of the osteoarthritis market and the needs of patients with this disease. We are confident that we have the team and the expertise to bring our solution to the world and make a significant impact on the lives of people with osteoarthritis. | We are looking forward to work with NITRO to accelerate the development of our technology with multiple labs techniques and start our clinical studies. |
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We have more than 20 years of experience treating patients with osteoarthritis and have done more than 30K thousands regenerative injection therapies in patients with severe osteoarthritis and published a clinical study showing we can grow cartilage in patients with stage 4 osteoarthritis |
| DataBiologics | Luke Malanga (luke@databiologics.com) Additional: leah@databiologics.com |
Mesa, AZ | DataBiologics is on a mission to accelerate patient access to innovation in healthcare through enabling providers, researchers, institutions, and payers with real-world evidence on safety and effectiveness of novel and regenerative treatments. We have one of the most-comprehensive database on outcomes data of regenerative treatments for Knee Osteoarthritis. | Being founded by physician thought-leaders is a key advantage, as many of DataBiologics early adopters are influencers, teachers, and authors. This makes our database that much more valuable. We also have a unique platform and team of experts who have expert knowledge in human-centered design and data analysis and visualization. This allows us to provide real time access to curated insights from a large, standardized database spanning all treatments in the regenerative field. | We are looking for partners with experience in insurance coverage and advancing access to treatments who would be involved in helping bring regenerative treatments to more patients. We also would like to partner with other technologies who are evaluating specific products or who are evaluating new methods for tracking objective measures for studying the efficacy of these treatments (wearables, computer vision models, etc.) |
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We can provide access to our unique technology that is tailored for tracking innovative regenerative treatments. We also already have one of the largest, proprietary, comprehensive, and standardized long-term outcomes databases in Regenerative Medicine today spanning numerous emerging applications. This data can be used for evaluation of products and advanced analysis on safety and efficacy. |
| University of Delaware | Anja Nohe (anjanohe@udel.edu) Additional: mcdermit@udel.edu |
Newark, DE | UD is a research-focused University with a wide array of programs, departments, schools, centers and organization with an enrollment of over 23,000. Within the University of Delaware are various centers to support research. On is he Delaware Center for Musculoskeletal Research (DCMR) supports basic and preclinical research on the central theme of musculoskeletal health—from the level of the joints to the actions of key cells and molecules—with emphasis on understanding the mechanisms by which physical and biological cues influence tissue structure and normal function and dysfunction, and identifying potential therapeutic interventions. | Extensive experience in cartilage regeneration by determining mechanisms of chondorgenesis and chondrocyte hypertrophy using in vivo and in vitro approaches, including explants. Access to OA cartilage from patients diagnosed with OA. Design of Delivery systems, 3D cellculture and potential therapeutics based on the BMP signaling pathway. The advantage is that our preliminary data suggest that there is no chondrocyte hypertrophy and full restoration of our used therapeutics. | We need help with preclinical and clinical trials, we have no expertise in this field. |
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The University of Delaware has successfully implemented the development of delivery systems, slow release systems and culture systems that can be used for cartilage regeneration. One of the treatments currently in development is a slow release system for cartilage regeneration. Early studies show the potency to restore cartilage back to 0 |
| Marine Biological Laboratory | Andrew Gillis (agillis@mbl.edu) Additional: asylvester@mbl.edu |
Woods Hole, MA | The Marine Biological Laboratory (MBL) is a basic biological and biomedical research institute with focus on 1) development of new and emerging aquatic models of cell/developmental biology and human disease, and 2) advanced imaging for biological discovery. The MBL is home to the Bell Center for Regenerative Biology and Tissue Engineering and the Bay Paul Center for Comparative Molecular Biology. Faculty at the MBL have extensive expertise in comparative molecular and developmental approaches to tissue regeneration, repair and engineering. | Cartilage derived from stem cells is plagued by a tendency to undergo unwanted hypertrophy and ossification, and this is a major problem for tissues destined for injection/transplantation into an articular cartilage injury. We have constructed a series of transgenes that recapitulate tissue-specific gene expression features that correlate with bone loss and retention of permanent, pre-hypertrophic cartilage in sharks and skates. Our work is focusing on the discovery of molecular regulators of permanent, pre-hypertrophic cartilage from fishes that could be used to arrest cartilage maturation in patient-derived cartilage, in order to ensure the longevity of this cartilage upon injection/transplantation into a joint injury. | Our work to date has focused on the molecular control of skeletal differentiation in fish and mouse models. We are keen to partner with clinicians and/or scientists working with patients and patient-derived cells, to explore how our bioinspired tissue engineering approach could be translated into treatments for articular cartilage injury and osteoarthritis. |
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The Gillis Lab at the MBL studies the molecular control of skeletal differentiation in cartilaginous fishes (sharks, skates, and rays). In mammals, cartilage is predominantly an embryonic tissue, forming a transient model for the future bony skeleton. Cartilaginous fishes, on the other hand, have lost bone, and have evolved a skeleton the remains permanently cartilaginous. These fishes have arrived at this innovation by arresting maturation of their cartilaginous skeleton, effectively locking their cartilage cells into a permanent embryonic (i.e., pre-hypertrophic) state. From comparative molecular, developmental, and genomic studies between cartilaginous fishes and mammals, we have identified genomic and gene expression features that correlate with bone loss and permanent cartilage in cartilaginous fishes. We are currently translating these discoveries to modulate and stabilize cartilage differentiation from mammalian progenitors, with the aim of enhancing and stabilizing patient-derived cartilage for transplantation into joint injuries. |
| Arizona State University | Abhinav P. Acharya (apachary@asu.edu) Additional: Kelley.C.Hall@asu.edu |
Tempe, AZ | Our research focuses on the energy metabolism of immune cells, osteoclasts, and neurons in osteoporosis, and rheumatoid arthritis. Moreover, we also focus on synthesizing novel biomaterials for drug delivery to affect the outcomes of these diseases. | Strengths - Key strengths include synthesizing novel biomaterials, drug delivery, immunology, and immunometabolism. Experience - Development of metabolites (e.g. alpha-ketoglutarate, itaconate etc.) based biomaterials, and studying their effect on the propagation of rheumatoid arthritis in various different mouse models, and osteoporosis. |
We are looking specifically at partners who have expertise in iPSC cells, large animal models, and access to human tissue samples of osteoporosis. |
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We can bring in the expertise of driving the generation of novel therapeutics and targets for drug delivery of metabolism-modulating metabolites, inhibitors among others that can then allow for understanding the role of energy metabolism and immune cells in disease progression. |
| Cleveland Clinic | Suneel Apte (aptes@ccf.org) Additional: aptess@gmail.com |
Cleveland, OH | Osteoarthritis/Proteases/Proteolysis/Proteomics/Degradomics/Protease Inhibitors. Our focus is on the proteases that break down the joint so we can, a: Determine when joint deterioration begins. b: Effectively target the proteases responsible for joint preservation early in the OA timeline. |
Our organization has strengths in clinical orthopedics, biochemistry, proteases and protease inhibitors. | We anticipate a team need for chemists, experts in drug formulation, delivery and regulatory affairs, along with veterinarians with expertise in large animal models. |
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We offer expertise in how the joint is broken down- this is important regardless of whether the goal is to prevent joint cartilage breakdown or rebuild the joint. |
| TZERMA LLC | Erming Tian (tianerming@att.net) Additional: mzangari@uams.edu |
Little Rock, AR | TZERMA, LLC is a biotechnology enterprise focusing on the translation of scientific research to the healthcare market. The vision of TZERMA is to develop solutions for metabolic bone tissue defects resulting from various aging-related diseases such as multiple myeloma and osteoporosis. | The breakthrough in creating new conceptual bone tissue engineering scaffolds came with TZERMA’s recent discovery on the mechanism of biomineralization in all somatic cells. This principle paradigm could potentially shift the industries of manufacturing bioceramic and building bone tissue substitutes with synthetic materials and biological HAP. | The technology of composite bone tissue substitutes. Animal (rabbit or larger) model assessment protocols and analytic methodologies. Government regulations. |
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TZERMA’s technology can in vitro construct 3D scaffolds pre-mineralized with biological hydroxyapatite (HAP) produced by the patient’s own cells. A patent application for this intellectual property has been filed with the United States Patent and Trademark Office. |
| Dorian Therapeutics | Maddalena Adorno (madda@doriantherapeutics.com) | San Carlos, CA | We develop novel small molecule to reactivate stem cell program that are dampen during aging. we developed several inhibitors for USP16, an epigenetic factor controlling stem cell and aging. we already demonstrated the efficacy of our approach in vitro and in vivo in several animal models, including models for autoimmune diseases, fibrosis and osteoarthritis. | Experience with regeneration of cartilage and epigenetic remodeling, identification of markers of aging and stem cells. very strong medicinal chemistry group, very strong stem cell background and aging biology | IND experience with previous OA programs, slow formulation, explant studies, large animal models |
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Experience with regeneration of cartilage and epigenetic remodeling, identification of markers of aging and stem cells. we are interested in partners to complete IND studies, run biomarkers studies related to aging signatures, and animal models. interested in slow release formulations for sustained efficacy |
| Phil and Penny Knight Campus for Accelerating Scientific Impact, University of Oregon | Marian Hettiaratchi (mhettiar@uoregon.edu) | Eugene, OR | The Phil and Penny Knight Campus for Accelerating Scientific Impact is an ambitious initiative to fast-track scientific discoveries into innovations that improve the quality of life for people in Oregon, the nation, and the world. The campus creates the intellectual infrastructure to establish Oregon as a center for both research and development. Our faculty and research teams have expertise in biomaterials, animal models of osteoarthritis and other musculoskeletal disease and injuries, brain-machine interfaces, protein engineering, DNA synthesis, biosensors, and bioinformatics. | Our vision is to dramatically shorten the timeline between discovery and societal impact through world-class research, training and entrepreneurship in a nimble scientific enterprise. We have significant strengths in collaborative work, interdisciplinary approaches, and innovation and entrepreneurship. | We are looking for teaming partners that can complement our expertise in biomaterials and small animal models with additional expertise in data science, large animal models, and clinical expertise. |
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We can offer our expertise in fabricating versatile biomaterials, animal models of musculoskeletal injuries and diseases, protein engineering, and the analysis of large datasets (-omics). |
| Rush University Medical Center | Rick Sumner (rick_sumner@rush.edu) Additional: anna_spagnoli@rush.edu |
Chicago, IL | Osteoarthritis and Cartilage, Total Joint Replacement, Bone Disease and Regeneration, Spine Degeneration and Small Molecule Therapeutics | 4 program project type grants related to joint health: UM1 on Acute to Chronic Pain in TKR, P30 entitled Chicago Center on Musculoskeletal Pain, UC2 entitled Mapping the Joint-Nerve Interactome of the Knee, T32 entitled Postdoctoral Training in Joint Health Multiple R-type grants related to bone and joint health |
Biomaterials expertise in designing IAI formulations, pharmacokinetics and dynamics, manufacturing, large animal modeling |
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~20 PI’s with a primary interest in bone and joint health, expertise in: Bone and cartilage biology and regeneration (single cell RNAseq to whole joint mechanics) High throughput screening for identifying lead compounds Small animal OA models, pain assessment Human functional testing and pain assessment Clinical Cartilage Restoration Center within a top 5 orthopedics department, experienced in clinical trials Multiple research cores, including Rush Imaging Research Core (RIRC) that houses a 3 Tesla Siemens Prisma scanner |
| University of Southern California | Denis Evseenko (evseenko@usc.edu) Additional: juliane.glaeser@med.usc.edu |
Los Angeles, CA | USC is a large scale university; our Team is focusing on osteoarthritis, chronic inflammation and age-related musculoskeletal decline. | Please see above | Expertise in aging and immunology of bone and cartilage diseases |
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Our Team’s strength includes deep knowledge of stem cell biology, cartilage biology, mechanisms of inflammation, arthritis, drug development, animal models of skeletal diseases, clinical trial design and execution, access and established pipeline enrolling highly diverse patients into clinical trials. |
| University of Illinois | Eben Alsberg (ealsberg@uic.edu) | Chicago, IL | Developing microenvironments, biomaterials and strategies to regulate cell behavior and engineering functional tissues. | Decades of musculoskeletal (e.g., bone, cartilage, osteochondral) tissue engineering, biomaterials, bioactive factor delivery, biomechanics expertise, bioprinting and animal defect model expertise. | We'd like to join a team where our technology and/or expertise in (7&8) above would be of value to the partnering proposal. |
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-cell condensation-based strategies to engineer cartilage, bone and osteochondral tissue -designer hydrogels (controlled physical, cell adhesive and bioactive factor delivery properties) and biomaterials for cell encapsulation to engineer cartilage, bone and osteochondral tissue -controlled bioactive factor (e.g., pDNA, RNA, growth factors) delivery systems -cell-only and cell aggregate 3D bioprinting strategies and technologies. -experience regulating the differentiation and behavior of MSC, EPSC, IPCS |
| NYU Cellular Reprogramming Team | Marcus Noyes (marcus.noyes@nyulangone.org) Additional: marcus.b.noyes@gmail.com |
New York, NY | The Noyes Lab at the NYU Grossman School of Medicine is interested protein domain function. We use high throughput synthetic screens to both understand protein function and to generate new proteins with novel functions. We use synthetic screens to do this so that we are not limited by the often narrow repertoire of domains that have evolved, allowing us to explore the true potential of a domain. We then apply this type of data to generate predictive models to understand the consequence of mutations and to design protein tools. Our lab has used this approach to create some of the most advanced models of homeodomains, PDZ domains, and Cys2His2 zinc fingers to date. We have focused much of our effort to understand DNA-binding domains used by transcription factors, generating a substantial amount of expertise in transcription factor function. We are interested in how these factors regulate targets as well as how they engage their DNA targets. With extensive experience in transcription factor biology, protein engineering, genome and epigenetic editing, our research focus provides a unique and powerful platform to apply to cellular reprogramming and the potential benefits for bone and cartilage regeneration. |
With a focus on the evolution of protein function, we have many years of experience developing and applying selection systems to screen large libraries that can manipulate protein or cellular functions. In addition, parts of the lab have developed several genome editing platforms that can be used to generated useful cell lines. From bacterial to mammalian cell selection systems, to investigating protein libraries with billions of members, the Noyes lab has the unique experience necessary to evolve regulatory programs that use fully human protein components. | Our team is well positioned to evolve protein systems that could generate bone and cartilage from precursor cells or iPSCs using novel regulatory proteins and networks. Our extensive background in genome editing will also be useful to set up selection lines and reporter systems. For this particular program, we are slowly expanding our knowledge base when it comes to bone and cartilage expertise. Thankfully an MD-PhD student that will be joining our team is particularly interested in this mission which will help provide some medical input, however, we would never call ourselves bone or joint experts. Partnering with teams that bring expertise using relevant cell lines such as Mesenchymal Stem Cells, Osteocytes and Chondrocytes, and/or expertise with useful animal models, would be extremely helpful. In addition, for in vivo applications, partnering with teams that offer expertise in the delivery of genetic materials, viral or non-viral, would allow us to bridge the gap between ex vivo and in vivo application of our tools. |
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We recently published the first AI-based model for zinc finger design and shown these synthetic domains can be used to reprogram transcription factors, directing them to novel positions in the genome. While the field has leaned on Cas9 for epigenetic editing, zinc fingers are by far the most common DNA-binding domain used by metazoan transcription factors, including half of the human factors. Therefore, reprogramming human transcription factors, with human-based zinc fingers, offers epi-editing tools with the least risk of immunogenicity. This will be critical for the safety of long-term in vivo expression and offers benefits in cellular reprogramming as ZF-TFs engage the DNA with mechanisms and affinities more similar to common transcription factors (e.g. the Yamanaka factors) than Cas9’s RNA-DNA hybrid. In addition, our approach “seamlessly” reprograms these factors by swapping in designed zinc fingers, allowing us to commandeer the function of just about any transcription factor and direct it to any sequence of interest. As a result, we bring our ability to design zinc fingers and reprogram a wide range of transcription factors that modify cell functions, that can be applied in vivo or ex vivo, and provide size benefits that enable delivery by any common technique. |
| Space-Aging Research Institute | Ian White (drwhite@spaceaging.org) Additional: kathy@neobiosis.com |
Alachua, FL | SARI is a spin-out from my company Neobiosis, which is a revenue generating, FDA-registered, FDA-inspected, cGMP-complient, regenerative medicine manufacturing company. The goal of SARI is to leverage the unique research opportunities in space to answer the most critical questions in aging and regenerative medicine. We are working on products developed by Neobiosis to generate novel bio-therapeutics for space travel and the aging population on earth. | SARI and Neobiosis work closely together. Our founder Dr. Ian White is also the CEO of Neobiosis who has over 20 years of experience in regenerative medicine and aging with a PhD from Cornell University, division of Regenerative Medicine. The CMO of Neobiosis is Dr. Pascal Goldschmidt, Dean Emeritus University of Miami School of Medicine. Neobiosis has been producing regenerative medicines for 2 years and recently received FDA approval for an IND to treat post-covid syndrome with a novel bio-theraputic. | We're looking for like-minded, motivated scientific collaborators. We approach innovative product development from a multidisciplinary perspective. We are reconciling biology, chemistry and physics to understand the true nature of aging and the mechanisms responsible for age-related disease. |
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Our laboratory is situated in the University of Florida Sid Martin Biotechnology Institute, which is currently recognized as the #1 biotechnology incubator in the world. Here we have access to all UF resources and core facilities to support our R&D efforts, which maximizes the impact of investment capital. Neobiosis, our mother company where our products were initially developed, was recently recognized by GrowFL as one of the top 50 2nd stage companies in Florida. We have a dedicated, qualified and experienced team. |
| Mechano Therapeutics | George Dodge, PhD (Gdodge@mechano-therapeutics.com) Additional: Nick@mechano-therapeutics.com |
Philadelphia, PA | Our prime focus is to revolutionize musculoskeletal health through our advanced drug delivery system for improving safety and efficacy. Utilizing our proprietary microfluidic fabrication process, we can encapsulate and release nearly any type of drug including small molecules, proteins, growth factors, and biologics. We focus mainly on intra-articular injectables but our technology functions as a platform and allows for other routes of administration as well. | We can encapsulate and release multiple types of drugs, varying routes of administration, and have demonstrated proof of concept in small and large animal models within therapeutic areas of joint inflammation, postoperative pain, infection, and cartilage regeneration. As a team, we have expertise in orthopedics, bioengineering, microfluidics, and clinical treatment of osteoarthritis and post-traumatic osteoarthritis. | Mechano is looking for co-developers with novel drugs that need a superb drug delivery vehicle for intra-articular joint injections or pharma partners with existing drugs looking to reformulate or develop combinational therapies for improved therapeutic efficacy. |
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Spun out of the University of Pennsylvania, we leveraged our understanding of mechanobiology and orthopedics to develop the first drug delivery system that uses the human body’s own natural forces to deliver therapeutics. Unlike traditional delivery systems, our novel technology allows for a more effective targeting method and for tunable drug release over time. This translates to site specific drug delivery, fewer drug administrations, fewer systemic side effects, and overall improved drug efficacy - all benefiting the patient. |
| Latham Biopharm Group | Jim Beltzer (jbeltzer@lathambiopharm.com) Additional: jarininger@lathambiopharm.com |
Elkridge, MD | Latham Biopharm Group is a full service Life Sciences consultancy. | Latham Biopharm Group has more than 20 years of experience in Cell Therapy, with expertise in cell therapy manufacturing and all the current modalities including CART and other gene modified cells, viral vectors, plasmids, mRNA and more. | Leveraging their proprietary cells and platform technologies to get to IND filling in 24 months. |
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Latham Biopharm Group is the representative of a biotech company developing regenerative medicine advanced therapies. |
| Chan Laboratory; Stanford University | Charles Chan (chazchan@stanford.edu) Additional: longaker@stanford.edu |
Palo Alto, CA | The Chan laboratory focuses on the biology of aging in stem cells and stem cell niches. Niches are the highly specialized but poorly understood microenvironments that regulate stem cell activity. Using a reductionist approach, our group pioneered techniques to identify and isolate stem/progenitor cells of individual tissue types, including bone, cartilage, and blood vessels (Chan et al., Cell 2015; Chan et al., Cell 2018; Zhao and Chan et al., ATVB 2023). The team, in collaboration with the Longaker group was the first to identify mouse and human skeletal stem cell (SSC), which have the ability to make bone, cartilage, bone marrow, and tendons but not fat. With these studies as a foundation, Dr. Chan and his group are now working to understand how aging affects stem cells in mammals, while developing new therapies to reverse the effects of aging to cure age-related diseases such as atherosclerosis, anemia, osteoporosis, and osteoarthritis. Recently the Chan lab have shown that resident SSC can be amplified with specific signals to the niche, causing SSCs to regenerate large amounts of articular cartilage to resurface the joints of mice and xenografted human limb tissues, (Murphy and Chan et al. Nature Medicine 2020). The Chan group are now working with colleagues at Stanford, UC Davis and other Institutions to translate these findings using large animal models in preparation for an IND filing to begin clinical testing of this method to reverse cartilage loss in osteoarthritis. |
Our laboratory has extensive experience in stem cell biology, computational biology, and bioengineering of skeletal tissues and have published extensively in these areas. We have also developed a stem cell oriented approach to understand the basis of age-related decline in skeletal tissues. | We would greatly appreciate the opportunity to collaborate with experienced partners in various fields, including biomaterials, surgical instrumentation development, imaging, development of GMP-grade materials, and regulatory control of processes. Our objective is to initiate investigational new drug filings and commence clinical trials under the supervision of the FDA. |
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Our research group have extensive experience in approaches to influence the activity of different types of stem cells and their microenvironment niches in skeletal tissues. We have developed multiple methods to decode the cross talk occurring in stem cells in these niches. We have also developed both chemical, and cell engineering approaches to deliver this cross talk in the form of protein factors to stem cells in vivo. These engineered signals commands skeletal stem cells (SSC) to expand and to produce the desired types of skeletal tissues, including, bone, tendons, and cartilage. |
| University of Texas at Arlington | Liping Tang (ltang@uta.edu) Additional: Michael.cho@uta.edu |
Arlington, TX | Dr. Tang is a Professor of Bioengineering at the University of Texas at Arlington. His group is actively working on the development of a new strategy to enhance tissue repair and regeneration by eliciting progenitor cell recruitment. Specifically, nano- and microscaffolds are engineered to accumulate on the injured tissue and then to release biomolecules to direct the recruitment and differentiation of autologous progenitor cells from the surrounding tissue. To combat osteoarthritis, his group has generated hyaluronic acid-based microscaffolds which can target and accumulate on the surface of injured and inflamed chondrocytes and cartilage. The released biomolecules can stimulate the recruitment and then proliferation of progenitor cells to produce ECM for regenerating and repairing injured cartilage tissue in situ. It should be noted that the bioengineering department has many faculties with extensive expertise in tissue engineering, drug delivery, and biomaterials. The research focuses include the synthesis and characterization of polymeric materials, hydrogel and adhesive, nanomedine for cancer and cardiovascular diseases, drug delivery for cancer and various inflammatory diseases. | The University of Texas at Arlington (UTA) is an emerging research powerhouse within the UT System and is accredited as an R1 Doctoral University. UTA offers the full range of support services expected at a research university. For example, the Shimadzu Institute for Research Technologies is comprised of multiple instrumentation facilities, each with a different research focus, and operated under the “centralized research resources” model. Centers within this Institute include Center for Advanced Analytical Chemistry, Center for Bio-Molecular Imaging, Center for Environmental, Forensic, and Material Science, Center for Brain Imaging, Center for Human Genomics, Center for Nanostructured Materials, Center for Materials Genome, Nanotechnology Research Center and Animal Care Facility. UTA Research Institute (UTARI)'s mission is to perform research and development linking discovery and technology commercialization to ultimately benefit society. UTARI services include Pre-production design, Product manufacturing process and optimization, Low cost and quick turnaround prototyping, especially for low-volume orders, In-line inspection and characterization, Product support system development, and Custom software development for process automation and product operation. | We are looking for teaming partners with established large animal osteoarthritis model(s), GMP manufacture capability, IND submission and/or osteoarthritis clinical trial expertise. |
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We have a broad spectrum of research facility and expertise for pre-clinical in vitro and in vivo testing which include material and scaffold characterization, drug release kinetics, cell/tissue compatibility and toxicity, small animal testing and histological analyses. |
| Tulane University | Chloe Ball (cball3@tulane.edu) | New Orleans, LA | The department of medicine is primarily focused on chronic diseases involving lung, heart, kidney, vasculature, stem cell, and regenerative medicine. | Biomedical research Stem Cell biology Immunology Epigenetics |
Biotechnology Interdisciplinary Science Aging Biology |
Regenerative Medicine Age-related diseases Chronic lung diseases |
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| TrialSpark | Niti Goel (niti.goel@trialspark.com) Additional: jordan@trialspark.com |
New York, NY | TrialSpark is developing sprifermin, a recombinant human truncated fibroblast growth factor 18 (rhFGF-18), for knee osteoarthritis (OA). Both clinical and nonclinical data demonstrate structure modifying potential in knee OA, leading us to believe that sprifermin has potential to be the first disease-modifying osteoarthritis drug (DMOAD) to be approved for cartilage regeneration in knee OA. Sprifermin has been administered intraarticularly in over 600 subjects across three clinical trials of knee OA. In the last Phase 2 study, FORWARD (NCT01919164), patients administered sprifermin showed statistically significant and dose dependent changes in femorotibial joint cartilage thickness vs placebo. While similar degrees of symptomatic improvement in WOMAC occurred for all treatment arms, a post hoc analysis identified a subgroup at risk for symptomatic progression who with sprifermin treatment showed improvement in both cartilage thickness and WOMAC pain score vs placebo. TrialSpark licensed sprifermin from Merck KGaA in January 2022 and is currently planning for further Phase 2 development in knee OA patients. |
TrialSpark’s core competency is running clinical trials faster and more efficiently. We have deployed our technology and recruitment practices in >300 studies on behalf of sponsor clients, but since 2021 we have reserved our “CRO-like” capabilities exclusively for the development of our pipeline programs. We have built a team of experts in program management, biostatistics, CMC, regulatory affairs, etc. with experience across rheumatology and immunology who are dedicated to supporting the continued development of sprifermin and TrialSpark’s other pipeline drugs. Our clinical stage pipeline consists of sprifermin, an oral dual JAK/SYK inhibitor, and a topical sodium channel blocker. We have raised >$250M to-date to support drug acquisition and development efforts across the TrialSpark platform. |
TrialSpark is interested in teaming opportunities with partners that, like us, are familiar with osteoarthritis drug development and its challenges but are open to novel trial designs and conduct. As sprifermin is best suited to address TA2 (cartilage regeneration), we hope to identify partners with complementary technologies that when combined with sprifermin would achieve both subchondral bone and cartilage regeneration. We are looking for a partner whose technology offers clear synergies and who is willing to be a partner not only in the asset, but in the brain trust as well. While risks taken can be calculated, we are not interested in unnecessary shortcuts. Partners should consider the voice of all diverse stakeholders (e.g., patient, provider, payer, regulator) in the drug development process. |
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TrialSpark is a next-generation pharmaceutical company that accelerates drug development using our proprietary, technology-driven drug development engine. By integrating technology, clinical operations, and R&D we streamline development processes, eliminate data silos, and pursue novel trial designs that reduce the cost and timeline of drug development. Our R&D team has been responsible for 45+ drug approvals and has expertise across rheumatology/immunology, dermatology, cardiovascular/metabolic, and neurology. TrialSpark’s end-to-end clinical development capabilities (Phase I-III) can offer NITRO and potential partners support in development strategy and execution across disciplines such as e.g., program design, regulatory affairs, clinical project management, trial design and monitoring, clinical data management, commercial strategy. |
| Idun Therapeutics | Balaji Sridhar (balcoccus@gmail.com) Additional: eddyfabery@gmail.com |
We are developing a novel cross-linked injectable Hyaluronic acid gel to deliver MSC derived exosomes to immunomodulate and treat knee OA. | We are young and have 2 medical doctors on the team who specialize in treating musculoskeletal injuries. We have a business development member getting an MBA from the University of Washington. We have renowned Biomaterials professor Kristi Anseth as our advisor and another graduate student who is dedicated to working on this game changing project. | Expertise with taking biomaterial products beyond regulatory hurdles and into the clinic. We would also like to partner with people who have exosome expertise and knowledge of the synovial joint immune environment. |
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We hope to be one of the possible therapeutic options to delay the need for knee replacement surgery and harness the power of the regenerative medicine to properly immunomodulate the joint and effectively delay the progression of knee osteoarthritis. | |
| Bruder Consulting & Venture Group, LLC | Scott Bruder, MD, PhD (scott@bruderconsulting.com) Additional: susan@bruderconsulting.com |
Franklin Lakes, NJ | Bruder Consulting & Venture Group (BCVG) is a full service strategic advisory and tactical execution firm with experience in MSK tissue repair and regeneration. Our team has experience in auto- and allogeneic cell therapy, bioactive molecules, biomaterials, gene therapy and combination products to manage osteoarthritis and other conditions. We are currently working on multiple programs to address OA and have obtained both IDE and IND approvals to initiate clinical trials of novel therapies. We have a rich history of obtaining FDA approvals for many RegenMed products currently on the market in orthopaedics. | BCVG is led by Scott Bruder, MD, PhD, and consists of a group of 20 advanced degree professionals with almost 400 years collective experience in musculoskeletal tissue repair and regeneration. We all come from industry where we have successfully developed and launched RegenMed products with biomaterials, cells and/or bioactive molecules. We have deep experience in PMA, BLA and NDA primary or combination products, including clinical design, execution and FDA navigation. We have also successfully obtained accelerated pathways through FDA with RMAT and Breakthrough Designations. | We are happy to support initiatives and teams who recognize the need for expertise and manpower in the fields of study and product development embodied in the NITRO program. Our philosophy is to collaborate and consider clients as partners along the product development journey. Shared success is our joy! |
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BCVG offers product development and partnering expertise along the entire pathway from concept, through preclinical design and testing, and eventually clinical design and execution with a focus on expedited regulatory approval regardless of the technology. We have experience developing and obtaining FDA approval for RegenMed products in bone, cartilage and other MSK tissues, as well as biomaterials and bioactives in osteoarthritis. We have dedicated team members who can both guide and execute on key initiatives. |
| University of California, San Diego | Robert Sah (rsah@ucsd.edu) | La Jolla, CA | The research focus of my Cartilage Tissue Engineering Lab is the biomechanics and mechanobiology of articular cartilage, synovial fluid, subchondral bone, and synovial joints, to improve the understanding, treatment, diagnosis, and prevention of musculoskeletal damage and deterioration. We study the following. Human Joints, Tissues, and Fluids-the natural sequence of events that occur with growth, after injury, during adult aging, and during the progression of osteoarthritis and osteoporosis. Tissue Models-mechanisms by which biomechanical and biological stimuli modulate cartilage metabolism and cause growth, maintenance, or deterioration. Engineered Tissues-mechanisms of cartilage and cartilage-bone interface growth and maturation, and effective treatments for damaged cartilage. Engineered Fluids-physiology of synovial joint fluid lubricants and regulators. Clinical Translation-how implants can effectively treat human cartilage damage. We use quantitative models and approaches and methods of biomechanics, mechanobiology, imaging, tissue engineering, regenerative medicine, cell and molecular biology, biochemistry, and histology. | I. Collaborative research team, working in interdisciplinary teams, ranging from clinicians to biologists and engineers. II. Published >250 peer-reviewed papers and >10 book chapters. Several of these have introduced novel methods for cartilage, osteochondral, and synovial joint biomechanics, mechanobiology, and tissue engineering that are directly relevant to the NITRO initiative. III. Completed >50 grants and service contracts. Many of these included endpoint analyses of human and large animal joints, both for biological mechanisms and outcome efficacy. Many have included interactions with companies, ranging from start-ups to established companies, and musculoskeletal tissue transplantation organizations. |
I. Collaborative researchers, able to work in an interdisciplinary team. II. Expertise in bone biomaterials for interfacing to chondrogenic tissues. III. Expertise with, or interest in, scale-up of human chondrogenic cells to the billions required for individual joints and the trillions required for 1,000+ joints, and for the industrial fabrication formation of chondrogenic tissues. IV. Orthopaedic surgeon(s) actively researching and conducting clinical trials of cartilage defects and/or osteoarthritis, and institutional experience and infrastructure to conduct such trials for multi-institution clinical trial. V. Musculoskeletal MRI evaluation of patients for a multi-institutional clinical trial. |
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I. PI and Investigating Team passionately undertaking science and engineering research in bioengineering solutions for damaged cartilage and osteoarthritis. II. Mechanobiological methods for fabricating osteochondral tissues for pre-clinical studies. (A) Tissue-scale bioreactors for osteochondral bioengineering, for rapid formation of osteochondral interface and cartilage of targeted shapes. (B) Dynamic joint-scale motion and loading bioreactors for whole joints, native and repair. III. Endpoint analysis of joint specimens, ranging from humans, to horse, goat, sheep, rabbit, rat, mouse, for structure, composition, function, metabolism. (A) Biomechanical tests for characterizing (A) cartilage biomechanical properties at scales ranging from zonal regions to tissue and joint scales, and for (B) lubrication properties of articulating cartilage surfaces by synovial fluid components. (B) 3D tissue histology and micro-computed tomography for structural and compositional analysis of cartilage, bone, and interfaces. (C) Biochemical analyses of cartilage extracellular matrix. |
| Hy2Care BV | Leo Smit (leo.smit@hy2care.com) Additional: kshama.sen@hy2care.com |
Geleen, Limburg, The Netherlands | CartRevive Hydrogel is a liquid, arthroscopically insertable implant, based on natural polysaccharides, that crosslinks in-situ to a solid membrane scaffold. It attaches to the surrounding and provides structural support and environment for cell growth, proliferation, and native matrix production. CartRevive has preclinical horse evidence of regenerating high-quality cartilage tissue, at par with best-in-class cell-based methods. Human clinical phase-I (First-in-Human) studies have been completed and a phase-II pivotal trial is ongoing. |
Hy2CAre is a spin-off from the University of Twente in the Netherlands and founded by prof. Marcel Karperien, who has been active in osteoarthritis research for several decades and has >240 publications and patents in this area. Hy2Care has developed hydrogel technology toward clinical quality standards. The team is very experienced in Sports Medicine business aspects and technically in the field of hydrogel therapies for cartilage and bone repair. Hy2Care's hydrogel platform is extremely versatile in combining with fillers and also can be tuned in mechanical properties, degradation rate, adhesion strength, etc. |
We want to partner with both technology suppliers as well as clinical institutions / clinicians, to develop and provide this full range of self- healing joint therapies in knee (femor, tibia, patella, mensicus) as well as applications in other joints. |
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We will submit our plans for a US trial in the knee, based on cell-free scaffolds for small cartilage defects and a combination with minced cartilage for medium-size defects. Extension of the therapy towards large defects is foreseen by developing a combination therapy with fabric membranes and cultured cells, possibly through an adapted hydrogel with elevated mechanical properties for fast load-bearing (NITRO - TA2). Further extension of the therapy towards sub-chondral defects is anticipated by combining the hydrogel with Demineralized Bone Matrix and/or Calcium Phosphates, creating an osteo-conductive matrix for bone repair (NITRO - TA1) |
| BHI Therapeutic Sciences, Inc | Elizabeth Mehling (emehling@bluehorizoninternational.com) Additional: dsantora@bluehorizoninternational.com |
Hackensack, NJ | BHI Therapeutic Sciences, Inc. (BHI) is developing a combined intravenous and intra-articular delivery of human MSCs to provide maximum benefit and effect from the cells. The fraction of MSCs being utilized offers the highest level of potency for therapeutic benefit as they exist in a more naïve state than adult bone marrow or adipose tissue derived MSCs. | BHI has treated OA with the less potent adipose derived MSCs. In a completed study, over 350 subjects with OA were treated with excellent safety and efficacy data. A recent safety study of the BHI MSC therapy and dosage (1x108 cells) was concluded in 2022. The study included 4 treatments for knee OA. Following a minimum 6-month follow on period, no adverse reactions occurred. Individuals treated with the MSCs abroad show recovery of tared cartilage over the course of 6-months post treatment. | BHI's Study Aims: Evaluate the efficacy of MSC treatment in an animal model of OA cartilage damage; Evaluate the efficacy of MSC treatment in an animal model of OA bone damage; Study the toxicity, biodistribution and tumorigenicity of the treatment for IND-enabling purposes. Conduct pilot GMP manufacturing runs; Submit IND request and receive FDA approval for clinical trials; Plan and conduct a pilot clinical trial to assess efficacy in cartilage and bone regeneration. |
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Extensive safety and efficacy data supports the use of human mesenchymal stem cells (MSCs) to improve outcomes of knee osteoarthritis (OA) by offering pain relieving (analgesic), immunomodulatory, and long-term functional and quality of life (QoL) improvements. Furthermore, the majority of clinical studies to date utilized either only surgical or intraarticular administration routes for MSCs, without considering the benefit of combining the routes of administration. |
| Stevens Institute of Technology | hwang2@stevens.edu | Hoboken, NJ | One of the current researches focuses on the biomimetic design of osteogenic biomaterials using various approaches such as 3D printing, emulsion, salt-leaching and so on. Besides, the team has also identified the osteogenic microenvironment to better guide the osteogenesis of human bone marrow mesenchymal stem cells and adipose-derived stromal cells, and so on. | Besides the technical strengths, we have a long record on collaboration with multiple teams. Furthermore, there is a rich experience in working with multiple investigators in a very organized and coordinated manner. Furthermore, the team is very creative with many very talented and hardworking researchers. | Looking for collaboration/partners with expertise in animal models and potentially clinical collaborators in the specialized domains. |
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In last a few years, the team has taken extensive efforts to develop injectable osteogenic microcarriers and established standardized dynamic culture systems to seed and culture bone-forming cells onto such micro carriers. While demonstrating the efficiency of the established platforms, we also explored the use of such cell-laden carriers to form 3D tissues with the opportunity to incorporate angiogenesis. Furthermore, such microcarriers can further tailored to contain various biomolecules for local release in order to induce the desirable biological responses. |
| Center of Biomedical Research Research Excellence (COBRE) in Skeletal Health and Repair, Rhode Island Hospital, Alpert Medical School of Brown University | Qian Chen (Qian_Chen@Brown.edu) Additional: RAlberg@Lifespan.org |
Providence, RI | The Center of Biomedical Research Excellence (COBRE) for Skeletal Health and Repair at Rhode Island Hospital/Brown University was established and supported by NIH (NIGMS) for the last fifteen years (2007-2023). It is a multi-disciplinary translational research center focusing on developing cell and molecular mechanism-based prevention and treatment of bone and joint degenerative diseases. The most important resource of the COBRE is a multi-disciplinary research team of scientists who have worked side by side and established long-term collaborations. The COBRE team includes cell and molecular biologists, aging research biologists, bioinformatic scientists, bioengineers, biomaterial scientists, tissue engineers, stem cell biologists, clinical researchers, rheumatologists, emergency medical doctors, and orthopedic surgeons. A common goal of the COBRE team is to cure osteoarthritis. | The strength of the COBRE is multiple fold. The first and foremost is its multi-disciplinary research team that have a long term (15 years) track record in successful collaboration and quality outcomes. The second is the established center infrastructure that includes administrative and technical cores and support personnel. The third is the rich experience and reputation in OA research. We have identified many candidate compound for OA treatment and we have developed key technologies for delivering these compounds. The RIH/Brown COBRE team will be ready for accomplishing ARPAH mission from Day 1. | We would like to enhance our bone regeneration and repair expertise by finding a teaming partners who have strong expertise in the area. |
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For the last fifteen years, the COBRE at RIH established a successful track record in making high impact discovery in cartilage and bone biology, establishing OA models in small animals (e.g, transgenic mice) and large animals (Yucatan minipig), and identifying candidate compound for OA treatment, which include small molecules, peptides, and nucleic acids. The COBRE contains high-caliber research infrastructure including Bioengineering Core and Imaging, Molecular Biology, and Nanomedicine Core. These core facilities are necessary not only for mechanical testing of cartilage and bone from tissue to molecular level, but also for drug delivery and assessing biological and clinical outcomes. The COBRE team is experienced in performing drug delivery with nanomaterials, drug screening in cell culture, testing drug efficacy, in vivo small and large animal models of OA, and clinical trials. |
| University of Rochester - Center for Musculoskeletal Research | Hani Awad (hani_awad@urmc.rochester.edu) Additional: Edward_Schwarz@urmc.rochester.edu |
Rochester, NY | The University of Rochester's Center for Musculoskeletal Research (CMSR) was established formally in 2000, building on a rich tradition of orthobiologics research. The CMSR is comprised of highly integrated faculty and trainees from various multidisciplinary departments pursuing research in a variety of research areas. Current research focuses with federal and various other agencies funding include: bone biology and disease, cartilage biology and arthritis, drug discovery and delivery, musculoskeletal stem cells, and tissue engineering. | The CMSR is a cohesive and productive team of musculoskeletal scientists with an internationally recognized reputation and significant NIH funding including P50, P30, T32, and numerous R grant awards. The significant extramural programmatic support and the success of individual faculty in winning federal grants have placed the CMSR among the top 5 NIH-funded musculoskeletal research programs since its inception in 2000, with more than $20M in extramural research funding in the current fiscal year. These successes are evident by published discoveries that not only advanced our basic mechanistic understanding of skeletal biology but are already impacting the clinic. Key members of the CMSR have substantial entrepreneurial history and experience with translating basic discoveries to clinical trials. | The translation of molecular targets into regenerative therapies requires two crucial partnerships. Firstly, the ability to load or attach them to an injectable hydrogel is essential. An optimal solution would involve partnering with scientists/engineers with expertise in developing lubricating hydrogels, preferably of biological origin, like Hyaluronic Acid hydrogels. These hydrogels can be engineered to include small molecules demonstrated to promote cartilage regeneration, allowing for sustained release upon intra-articular injection. Secondly, collaboration with pharmaceutical partners is vital to produce pharmaceutical-grade regenerative drugs based on the identified small molecules, following the guidelines of current Good Manufacturing Practices (cGMP). These partnerships ensure the production of high-quality and compliant therapies for clinical use. |
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Key Technologies/Resources 1) Reporter and targeted gain- and loss-of-function preclinical models 2) Single cell transcriptomics libraries from inflamed human OA joints 3) Human iPSC models of cartilage regeneration and degeneration 4) Novel human Joint-on-a-Chip for small molecule discovery and testing 5) Several molecular targets for cartilage regeneration (PTH, WNT16, FGF18) 6) State-of-the-art human motion and joint performance analysis |
| Van Andel Research Institute | Tao Yang (tao.yang@vai.org) Additional: OSR.vai.org |
Grand Rapids, MI | Van Andel Institute focuses on bone health, cancer, Parkinson’s and Alzheimer’s, Epigenetics and health, Environment and health, immunology, metabolism and nutrition, rare disease, depression, and structural biology, etc. The research of PIs was fueled by strong cross-disciplined collaborations, which are leveraged by state-of-the-art core technologies. Details can be found at: https://www.vai.org/research/research-areas/ https://www.vai.org/research/ https://www.vai.org/research/core-services/ |
Van Andel Institute houses 5 departments: Cell Biology, Epigenetics, Metabolism, Neural Degenerative diseases, and Structure biology. Skeletal biology, stem cell biology, animal models, genetics, epigenetics, metabolism, immunology, -omics, and bioinformatics are the strengths of the institute related to NITRO. In addition, the institute also encourages cross-institutional collaborations and has established a well-functioning mechanism and experienced teams to facilitate the translation of basic research to the clinics. As evidenced by VAI/Stand up to cancer epigenetics dream team and partnership with Cure Parkinson’s to support clinical trials for neural degenerative diseases (details at: https://www.vai.org/research/collaborations/) |
We seek partners who complement our research capabilities. Specifically, we have successfully established strong basic research programs that study how to improve bone and cartilage health by interconnecting mesenchymal or pluripotent stem cell engineering, tissue regeneration, epigenetics, and metabolism. In the next phase, we look forward to teaming with PIs with strong expertise in osteoarthritis-related clinic research, who can provide clinic samples and opportunities for future clinical trials. We also look forward to collaborating with experts in tissue engineering and biomechanics. But we have found this is simply a starting point to successful partnering. We evaluate partnership opportunities along the following parameters: Expertise: partners who have demonstrated expertise in complementary areas of research to which we can add value; Communication: partners who communicate openly and honestly confident in challenging, accepting, and aggregating ideas to benefit the team; Collaborative Mindset: partner should be willing to work as part of a team and have a genuine interest in collective success rather than personal gain. Reliability and Commitment: partners with demonstrated team success to meet deadlines, delivers on the promise, and contribute consistently. Ethics and integrity: partners who adhere to ethical guidelines, value scientific rigor, and prioritize transparency and reproducibility in their work. |
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Van Andel Institute (VAI) prides itself on our commitment to fostering team science from our foundation up. Collaboration is a foundation value at VAI, believing that only diverse disciplines working together without restriction can we tackle tomorrow’s complex scientific challenges. One key aspect of VAI's team science approach is the establishment of multidisciplinary research teams not limited to our four walls. As our Chief Scientific Officer, Peter Jones, PhD, DSc describes our unique approach, ""We are an institute with and without walls. It is the essence of what we do that is different from anyone else. By combining different fields of knowledge, such as genetics, biochemistry, and computational biology, our cross-institution teams are able to generate comprehensive insights and discover new knowledge for translation. We believe By forging alliances, sharing data, and collaborating on large-scale projects, the VAI expands its scientific reach and maximizes the impact of its research efforts. |
| CollaMedix Inc. | Ozan Akkus, PhD (ozan@collamedixinc.com) Additional: subba@collamedixinc.com |
Cleveland, OH | CollaMedix Inc. is a start-up company that is active in the area of implantable musculoskeletal biologic materials. Specifically, the company specializes in GMP-manufacturing of collagen monofilaments in continuous length on spools using the scalable and patented electrochemical compaction process. The spools can be fed into a variety of textile processes such as braiding, weaving or knitting to obtain pure collagen biotextiles that are trademarked under the name CollaFabric. CollaFabric is macroporous for cell seeding in regenerative strategies, and also it guides directional and aligned host tissue ingrowth and vascularization. Textiles can be crosslinked post-hoc to varying degrees to tailor the degradation timeline for the specific application ranging from a few weeks to a year. | CollaMedix has grown since 2019 through multiple Phase I and Phase II SBIRs from the State of Ohio, NIH and NSF for developing soft tissue regeneration products for rotator cuff repair (CollaSleeve) and stress urinary incontinence repair (CollaSling). CollaSleeve is on track for 510(k) submission in 2024. Biocompatibility tests of genipin crosslinked collagen filaments by a third party have passed essential tests. Through the process of developing CollaSling and CollaSleeve, CollaMedix amassed essential translational experience in Q-sub meetings with the FDA, establishment of GMP production, working cooperatively with GLP-preclinical large animal testing partners, validation of sterility and endotoxin levels, clinical trial planning with multiple sites, and strategic operation through feedback from our scientific and medical advisory boards. | Osteochondral CollaFabric concept would synergize with partners who are established in cartilage/bone cell expansion and seeding, bioreactor and perfusion capabilities for in vitro conditioning of cell-seeded biofabric, experts who can manufacture biodegradable bone backing based on 3D reconstruction MR/CT images from patients, those groups that are established in preclinical animals models for sizeable osteochondral defect repair, and companies or centers specialized in biomedical textile space. |
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Collamedix can provide an osteochondral fabric that is load bearing, cell-seeding receptive, and flexible to conform to curviplanar surfaces, be it a resurfaced joint, or an artificially made lab-grown bone-mimicking constructs. In pure collagen form, Collamedix textile accommodates cartilage growth while suppressing osteogenic differentiation. At the same time, the CollaFabric becomes osteoconductive through infusion with hydroxyapatite, which we demonstrated in vitro and in vivo. Purposeful combination of cartilage and bone forming monofilaments as a biphasic osteochondral fabric presents itself as an ideal lining for the joint surface. Strength of collagen monofilaments converge to that of native tissues; thus, the osteochondral fabric can accommodate in vitro loading during biomechanical conditioning, and in vivo loads during post surgical deployment, with or without cells. Monofilaments are woven in an arch-like fashion in the cartilage layer, mimicking the native directionality of cartilage’s collagen phase, to bear compressive loads in a physiologically relevant fashion. Being made of collagen, chemical conjugation of therapeutic agents to drive osteochondrogenesis is feasible with CollaFabric through simple chemistries. |
| Homer Stryker MD School of Medicine, Western Michigan University | Yong Li MD, PhD (yong.li@wmed.edu) | Kalamazoo, MI | We are looking for partners or collaborators in the translational or clinical studies in order to advance our recent findings about the use of autologous blood products to speed up tissues' regeneration after injuries or diseases. | Utilizing autologous blood products can help overcome many of the present limitations in regenerative medicine. Especially in clinical application... | Clinical studies as well as can create big animal models and surgeries. |
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We are able to provide the mechanisms behind and specific instructions for what our investigation discovered, including rodent studies. |
| City of Hope / Stanford / Palo Alto VA Hospital | Ed Boas (fboas@coh.org) Additional: sirish.kishore@stanford.edu |
Duarte, CA; Palo Alto, CA | City of Hope: Deliver the right drug, to the right place, at the right time. Our lab develops new devices and materials for local drug delivery (intra-arterial or percutaneous). We test new drug-eluting hydrogels, microparticles, glues, and devices in a pigs, prior to translating into human trials. Stanford / Palo Alto VA: We started a prospective trial of embolization for the treatment of osteoarthritis in the knee, shoulder, and hip, including perfusion MRI to identify areas of abnormal neovascularity. |
• Interventional radiology. We have performed thousands of image-guided procedures (percutaneous and intra-arterial) in humans and pigs, including geniculate artery embolization. • Bioengineering. We develop and characterize new polymers, microparticles, and devices for local drug delivery. • Clinical trials. We have extensive experience running clinical trials of image-guided procedures, including geniculate artery embolization. • Bench-to-bedside translation. We have a track record for developing new tools for diagnostic and interventional radiology, and bringing them into routine clinical use. |
Groups that have new drugs and cellular therapies that would benefit from image-guided local delivery. |
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We can deliver cells, drugs, and materials into the joint, or into the artery supplying the joint, to promote joint repair. |
| Panorthopaedics, Inc. | Rajiv Pandya, MD (info@panorthopaedics.com) Additional: ruturaj.patil@panorthopaedics.com |
Atlanta, GA | Our research is centered around addressing Subchondral Bone Marrow Lesions (SBMLs), defects often found in the subchondral bone. These lesions can cause severe pain, restrict mobility, and potentially escalate to more severe pathologies such as progressive osteoarthritis if not managed correctly. The existing surgical procedures, though aiming to alleviate interosseous pressure and promote healing by injecting stabilizing agents or other biomaterials, are cumbersome and suffer from inaccuracy. Additionally, given the absence of effective guide systems, the drilling is generally performed free-hand towards an elusive target potentially leading to misplacement of materials exacerbating symptoms and pathology. Therefore, we are focusing on the development of a novel, minimally invasive system that enables precise targeting, intraarticular guided access, and delivery of healing biomaterials to SBMLs. | Our strength lies in our diverse and experienced team, led by a practicing surgeon with extensive experience in innovative osteoarthritis treatments and a CEO boasting 30 years in orthopedics and regenerative medicine. Our Panplasty system has passed cGMP and other regulations and has been employed in over 50 cases involving a range of biomaterials, all without any complications. We're in the process of extending our program and implementing patient experience evaluations to determine outcomes specifically looking at TKAs. | We are looking for partners who can supplement our three-pronged treatment approach focusing on intraarticular, intraosseous, and biologics. We are open to partnerships with organizations that can offer innovative biomaterials or techniques to comprehensively address osteoarthritis-related pathologies. |
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Our organization has developed and patented an innovative system that allows for the precise and consistent targeting of BMLs, irrespective of the type of biomaterial used. This platform can significantly advance the delivery of various therapeutic biomaterials, including stem cells and stabilizing factors, directly to osteoarthritic lesions in the subchondral bone. Moreover, we offer potential partners opportunities for clinical evaluations with patient-reported outcome tracking. Additionally, we provide networking opportunities with pioneering surgeons in the field. |
| University of Pittsburgh | Juan M Taboas (jmt106@pitt.edu) Additional: aja19@pitt.edu |
Pittsburgh, PA | Articulating joint health and pain, biomechanics of degeneration, tissue modeling and drug screening, and regenerative approaches using biomaterials, drug-delivery, gene editing, and cell-based therapies. | The University of Pittsburgh has been in the top 10 of NIH funding since 1998, moving to 3rd last year. The University is a leader in regenerative medicine, organ and cell transplantation, and clinical orthopedics. The team comprises faculty across the Swanson School of Engineering and the Schools of the Health Sciences, with appointments in the McGowan Institute for Regenerative medicine, the Pittsburgh Center for Interdisciplinary Bone and Mineral Research, and the Clinical and Translational Science Institute. | Seeking partners with expertise in: • iPSCs for allogenic therapy • Immunomodulation • Metabolic profiling • 3DP of patient specific scaffolds • Clinical trials |
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• Bioengineering including joint biomechanics and biomaterials • Joint innervation and pain. • Large animal models of bone and cartilage regeneration (pig, goat) • Bone and cartilage regeneration assays including micro-CT • In situ CRISPR-based gene therapy • Bone marrow stem cell-based therapy • Decellularized ECM, hydrogel and sponge biomaterials |
| Massachusetts Institute of Technology | Ronald T. Raines (rtraines@mit.edu) | Cambridge, MA | We have more than 25 years of experience with collagen, which is by far the most abundant protein in the extracellular matrix. Recently, we developed collagen-mimetic peptides that can anneal to damaged collagen (as in osteoarthritis) but not to healthy collagen or to themselves. We have demonstrated the efficacy of this targeting in vitro, ex vivo, and in vivo (mice). With a pendant MRI contrast agent, these peptides can diagnose collagen damage. With a pendant drug, these peptides can treat the cause of collagen damage (e.g., osteoarthritis). | MIT attracts many of the best graduate students and postdoctorates in the world. Moreover, the MIT campus is located in Kendall Square, which is a worldwide epicenter for biomedicine and biotechnology. | We are looking for teaming partners that could work with us to exploit the anchoring of pendant probes and drugs near damaged collagen in osteoarthritic tissue. |
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We have an established platform that is the functional equivalent of antibody-drug conjugates but with a much simpler modality. |
| Cell Sheet Tissue Engineering Center, The University of Utah | David Grainger, Ph.D. (david.grainger@utah.edu) Additional: makoto.kondo@utah.edu |
Salt Lake City, UT | We have exclusive supply agreements and rights to develop allogenic, patented cell sheet technology to address unmet clinical needs. Our focus currently is on use of GMP-grade human MSCs as well as juvenile chondrocytes harvested from polydactyly surgical discards as viable, scaffold-free cell sheets to regenerate subchondral bone and cartilage. We have access to novel arthroscopic deployment devices (4-mm diameter) for cell sheets for minimally invasive sheet suture-less deployment in synovial spaces. We have demonstrated proof-of-concept for banked polydactyly-derived chondrocytes from ~50 donors regenerating hyaline cartilage in athymic rat cartilage defects. Our Japanese clinical partners report clinical studies using autologous and allogeneic polydactyly cell sheets to regenerate cartilage in surgical instrumented osteotomy microfracture treatment in late-stage human OA patients. We also have preliminary evidence that this approach also influences subchondral bone repair. This technology using a scalable, banked, economic, validated allogenic human cell source is maturing rapidly and highly translational: 3x104 cell sheets can be fabricated from a single human surgical discard donor passage 4. Colorado State University veterinary partners provide their published equine cartilage regeneration model, novel ready-to-use juvenile equine chondrocyte cell bank, and also an adult equine MSC cell bank already deployed in equine cartilage regeneration models. |
Our team comprises stem cell biologists, bioengineers, equine surgeons specializing in orthobiologic cartilage and bone repair, clinical orthopedic surgeons, and business management personnel. | • GMP cell manufacturing • Regulatory pathway guidance for IND submission • Clinical partners |
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We have unique know-how and scalable technological capabilities to produce scaffold-free adhesive human chondrocyte cell sheets that regenerate cartilage from banked human clinical grade MSCs and juvenile chondrocytes. The technology is advanced to pre-IND submission. We have access to innovative arthroscopic cell sheet deployment device technology. We are partnered with a well-known equine cartilage regeneration team at Colorado State University (PI L. Goodrich) and their unique equine research models and resources, including a ready-to-use juvenile equine chondrocyte cell bank. |
| Cellatoz Therapeutics | Craig Southern (southern@cellatozrx.com) Additional: hjkim@cellatozrx.com |
Seoul, Korea / London, U.K. | Cellatoz have developed an innovative source of musculoskeletal stem cells (iMSSC) induced from human pluripotent stem cells. iMSSCs are a homogenous population generated readily for clinical and commercial applications. When transplanted into the bone, tendon, cartilage, and muscle in mice, iMSSCs tissue-adaptively differentiate into these respective tissues, adjusting their cell fates to match their surrounding environment. iMSSCs are a unique cell source for treating musculoskeletal disorders in alignment with ARPA-H NITRO TA1 and TA2 |
Cellatoz take innovative approaches to generate unique, patented stem cell sources for regenerative cell therapy across neuronal, musculoskeletal and immune therapy indications. Cellatoz has expertise in the implementation of robust manufacturing procedures for allogeneic and autologous therapies ensuring consistent supply of functionally active products. Our neuronal regenerative therapy recently entered a Phase 1 clinical trial in Korea for peripheral neuropathy. | Cellatoz Therapeutics seek interested academic, clinical, regulatory and CRO/CDMO partners to assist in the successful progression of iMSSC toward the patient in US Phase 1 clinical trials. |
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Cellatoz Therapeutics can offer iMSSC for validation of therapeutic efficacy in relevant models and process development knowledge for scalability |
| Kytopen | Paulo Garcia (pgarcia@kytopen.com) Additional: bgrant@kytopen.com |
Cambridge, MA | At Kytopen, we focus our research on non-viral gene delivery technologies that can empower researchers and developers to accelerate drug discovery, expedite optimization, and remove barriers to biomanufacturing at scale. Our platform technology, Flowfect®, combines continuous fluid flow with electric fields for high-efficiency delivery of payloads such as mRNA, DNA, and CRISPR Cas RNP to billions of cells in minutes. The Flowfect® continuous process enables unprecedented customization to finetune the delivery of genome engineering materials to cells and allows predictive scaling from small volume transfections to manufacturing at scale. We are currently funding internal research towards improvements of our platform, machine learning models, and providing proof-points for various cell and gene therapy applications. Some of our research focuses on the development of novel materials that can improve various performance metrics for our consumables such as yield of engineered cells, transfection efficiency, volume capacity, and novel computational approaches towards cell engineering optimization, to name a few. Additionally, we are constantly working with various cell types and payload constructs towards generating proof-points or white papers that provide our customers and collaborators with reference data, analytical methods, and workflows. |
Kytopen has a strong collaborative and multidisciplinary team, commercialization experts, industry advisors, and investors. There are currently ~30 full-time employees combining expertise in gene editing, immunology, microfluidics, manufacturing, automation, product design & development, business development, sales, and engineering. Paulo A. Garcia, Ph.D. is the CEO & Co-Founder, and co-inventor of the Flowfect® technology. Dr. Garcia is scientist by training and entrepreneur by DNA who brings 15+ yrs on pulsed-electric-field technology and an unwavering will to help patients suffering from devastating diseases worldwide. Greg Crescenzi , CCO, brings 30+ years of life science leadership experience, researching, developing, marketing, and/or selling integral products that helped advanced the biotechnology industry. He joined Kytopen after Cytiva where he served as the Enterprise Delivery Leader. Bethany Grant ,CTO, oversees all R&D at Kytopen. Bethany previously led innovation efforts at Johnson & Johnson as R&D Director in various roles including development of minimally invasive solutions for knee, shoulder, and hip injuries within the DePuy Synthes. Cullen R. Buie, Ph.D. Co-Founder and Tenured Professor of Mechanical Engineering at MIT. Dr. Buie currently serves as a Board Director, Advisor & Chair of the Scientific Advisory Board. Cullen brings expertise in the areas of microfluidics, microfabrication, and fluid mechanics. |
Osteoarthritis scientific lead: Ideally a researcher at the scientific forefront of cell therapies for osteoarthritis who has identified potential genetic targets and approach but missing cell engineering technologies that can accelerate early research efforts and efficiently transfer findings to the clinic. Clinical experience with therapies for osteoarthritis applications: Kytopen is looking to partner with leaders in the field that have previously led clinical research, including clinical trials, for osteoarthritis applications. Manufacturing capabilities suitable for clinical cell therapy work: Kytopen is currently not able to house manufacturing operations in compliance with good manufacturing practices (GMP) for cell therapies. We are seeking partners with existing infrastructure to accelerate development efforts into the clinic. Regulatory compliance: Regulations will likely change depending on the target approach, which is why engaging regulatory experts within the cell and gene therapy space from the beginning will be critical to the success of the program. While Kytopen has access to resources with expertise on regulatory compliance for transfection technology, it is critical to get a comprehensive, end-to-end, assessment early in the program including support from PATIO. |
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Kytopen has pioneered a non-viral, continuous flow electro-mechanical transfection technology called Flowfect® which relies on simultaneous application of electrical energy and continuous high fluid flow rates to permeabilize mammalian cells. This high efficiency, high viability approach utilizes the same flow cell for a 96-well array optimization studies and clinical scale manufacturing, overcoming scale-up challenges. Kytopen’s multidisciplinary team covers a wide spectrum of areas relevant to autologous and allogeneic cell therapy. Our biology team includes experts in cell therapy manufacturing process development some of whom have played an essential role in the successful commercial launch commercially-available engineered cell therapies. Kytopen’s engineering team has led product development efforts around liquid handling automation, single-use disposables, buffer and cell culture media formulation, and electromechanical systems. Kytopen is well suited to support transfection process development, analytical development towards target product profile and critical quality attributes, and software and automation efforts leading to a customized osteoarthritis cell therapy manufacturing workflow. The Flowfect’s high-throughput nature can accelerate the development of an engineered cell therapy by an order of magnitude and is ideally suited to support the NITRO’s mission. |
| Baylor College of Medicine | Brendan Lee (blee@bcm.edu) Additional: bae@bcm.edu |
Houston, TX | We are interested in understanding the pathogenesis of post-traumatic osteoarthritis (OA) by using preclinical genetic mouse models and surgical OA mouse models such as destabilization of the medial meniscus (DMM) and ACL transection (ACLT). With these in vivo models, we focus on developing combinatorial gene therapy with candidate gene approach (Prg4 and/ or IL1RA) using helper-dependent adenovirus (HdAds) to modify OA progression and/or pain level. The assessment of OA progression and the efficacy of gene therapies are evaluated by the high resolution phase contrast microCT 3D imaging and the 2D histological analysis of knee joints. Also, behavior studies, including hot plate analysis, Von frey and gait analyses, are performed to evaluate the functional correlation of OA and pain level. With our research, it will facilitate to identify the potential therapeutic targets for OA progression which may allow to regenerate the joint cartilage and modulate inflammation and/or pain in joint tissue. | We are experts in mouse genetics which allow us to model human genetic disorders or common skeletal disorders such as OA. With these expertise and the combination of surgical OA models, we can define the function of candidate genes in OA progressions. We are experienced in designing and developing in vivo gene delivery platform for small and large animal models. We have also established SOP of performing a high-resolution microCT 3D imaging and histological 2D OA knee analyses and OARSIS scoring system. Our multi-disciplinary researchers have long successful track records in musculoskeletal biology and gene delivery system that we can deliver impactful outcomes in bone/ cartilage regenerative research. | We are looking for collaborators who have expertise in assessing live, in vivo assessment of cartilage growth. |
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Our team can offer preclinical genetic mouse models and surgical OA mouse models. We have well-established gene delivery platforms using Hd-Adenovirus which allow us to perform combinatorial gene therapy. We also have a standardized high-resolution phase contrast microCT 3D imaging for joint tissue. The pain and/ or functional outcomes of OA are assessed by the behavior core in Baylor College of Medicine. In addition, our institute is equipped with a state-of-art Advanced Technology Core labs (https://www.bcm.edu/research/atc-core-labs) that have capability to deliver CRISPR-CAS9 directed genetic mouse models, Single cells spatial transcriptomics and etc. |
| Rush University Medical Center | Anna Spagnoli (anna_spagnoli@rush.edu) | Chicago, IL | There over 20 investigators at Rush University that do translational and clinical research in bone & joints. | Our strengths are in: 1) in vitro and animal studies (surgically-induced or genetically modified models for OA) to mechanistically study cartilage degeneration and OA-related pain; 2) studies on human chondrocytes and human joints (from organ donors) with wide range degree of histological OA; 3) sustained delivery of proteins, using chitosan; 4) tribology laboratory to simulate joint articulation; 5) joint prosthesis toxicity; 6) nationally and internationally recognized excellence in Orthopedic clinical care (Midwest Orthopedics). Teamed investigators at Rush have T32 and P30 grants on bone & joints. | We are looking teaming with investigators that are conducting studies: 1) on large animal models for OA; 2) on tissue engineering. |
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We can offer: animal and cellular studies; tribology lab; potential clinical collaborations. |
| UCSF Musculoskeletal Center | Tamara Alliston (tamara.alliston@ucf.edu) Additional: cristal.yee@ucsf.edu |
San Francisco, CA | SUBCHONDRAL BONE: We have expertise in the role of subchondral bone in OA. Our team discovered mechanisms by which bone cells cause joint shape change and OA. We have local and systemic bone targeting compounds with outstanding potential to treat OA based on preclinical and clinical data. PRECISION OA DIAGNOSIS: OA is not just one disease. Our team integrates quantitative human musculoskeletal imaging, machine learning, statistical genetics, and epidemiology to identify which patients should get which treatment, especially in the metabolic disease and obesity. TRANSLATIONAL INFRASTRUCTURE: Our team built robust infrastructure to guide and drive projects from academia to clinic together with corporate partners in manufacturing, licensing, and clinical trial preparation. |
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| Regenosine | Sid Angle (sid@regenosine.com) | Princeton, NJ | We are focused on developing and marketing first-in-class regenerative therapies for musculoskeletal diseases. Our proprietary platform technology harnesses the healing potential of the purinergic system which plays a critical role in maintaining tissue homeostasis. Our lead product is a proprietary formulation for regenerating cartilage in joints with established osteoarthritis, targeting a rapidly growing joint preservation market. | Team of subject matter experts with 100+ years of combined experience in the field of OA, scientific entrepreneurism & orthopedic product commercialization | Clinical collaborators support the initiation of our Phase1b/2a clinical trial designed to evaluate an early clinical proof of the analgesic, anti-inflammatory and disease modifying effects of our treatment in osteoarthritis. Research and pre-clinical collaborators for indication expansion into other areas of musculoskeletal disease indications. |
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IP protected core technology which is a regenerative for cartilage and bone regeneration available for clinical development through an expedited pathway with the FDA. |
| Boston University | Jeroen Eyckmans (eyckmans@bu.edu) Additional: efmorgan@bu.edu |
Boston, MA | Current research areas are developing strategies to promote healing of critical sized bone defects. The technologies we develop range from 3D printed scaffolds and pro-regenerative hydrogel systems (for vascularization and bone) to investigating the role of mechanical cues and senescence on skeletal tissue repair. | We have strong expertise in scaffold design, human progenitor cells, bone tissue engineering, vascular engineering, mechanical testing and mechanobiology. | We are looking for teaming partners who are experts in cartilage regeneration, immune modulation, and large animal models. |
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We have designed an experimental approach to rationally design scaffold architectures that maximize vascular bone regeneration with human cells. This technology can drastically reduce the number of iterations needed to design and manufacture a scaffold that promotes bone growth in an engineered osteochondral implant. |
| Mayo Clinic | Matthew Abdel (abdel.matthew@mayo.edu) Additional: roesler.anne@mayo.edu |
Rochester, MN | Mayo Clinic is a charitable, non-profit academic medical center that provides comprehensive patient care, education in clinical medicine and medical sciences, and extensive programs in research. The Mayo Clinic Department of Orthopedic Surgery celebrated its 100th anniversary in 2010 and has been ranked in the top two orthopedic surgery departments by US News and World Report for the last 20+ years. Our Department’s research priorities include discovery science, artificial intelligence, clinical trials, and regenerative medicine. We also look forward to developments in the areas of individualized medicine and virtual orthopedic clinical trials. | Mayo Clinic Department of Orthopedic Surgery investigators conduct basic research and perform clinical trials and other clinical research in virtually every aspect of musculoskeletal (MSK) pathology. In 2022, our department spent ~$15 million in support of research efforts and our findings were completed greater than 400 peer-reviewed publications. Mayo Clinic Department of Orthopedic Surgery faculty continue to serve in leadership roles in national orthopedic groups, including the American Academy of Orthopedic Surgeons, American Board of Orthopedic Surgery, Association of Hip and Knee Surgeons, Orthopedic Research Society, American Society for Bone and Mineral Research, American Orthopaedic Foot and Ankle Society, Mid-America Orthopaedic Association, American Association for Hand Surgery, and American Academy of Physical Medicine and Rehabilitation. The Department of Orthopedic Surgery maintains three large clinical registries (Mayo Clinic Total Joint Registry, Periprosthetic Infection Joint Registry, and Orthopedic Trauma Registry). The Department of Orthopedic Surgery has a T32 Musculoskeletal Research Training Program (PI: Dr. Jennifer J. Westendorf). The program provides opportunities for basic and clinical musculoskeletal research projects. Our studies are also supported by the Mayo Clinic Core Center for Clinical Research in Total Joint Arthroplasty (CORE-TJA), a core center for clinical research funded by NIAMS (PI: Dr. Daniel J. Berry). |
We are seeking partnerships to deliver impactful outcomes on the MSK front as we carry out our Mayo Clinic mission of inspiring hope and contributing to health and well-being by providing world-class care to every patient through integrated clinical practice, research, and education. We seek partners whose expertise will synergize with our strengths to bring forward innovative and meaningful improvements in the care of MSK patients. |
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Mayo Clinic Department of Orthopedic Surgery investigators conduct basic research and perform clinical trials and other clinical research in virtually every aspect of musculoskeletal (MSK) pathology. The Department of Orthopedic Surgery maintains three large clinical registries (Mayo Clinic Total Joint Registry, Periprosthetic Infection Joint Registry, and Orthopedic Trauma Registry). |
| University of Central Florida College of Medicine, Kean Cell and Tissue Engineering Lab, Biionix Cluster | Thomas Kean (thomas.kean@ucf.edu) Additional: thomas.kean@ucf.edu |
Orlando, FL | Engineering and characterization of primary human chondrocyte extracellular matrix reporters for anabolic drug discovery and determining cell instructive formulations for 3D printing and bioprinting. This is enabled by a synoviocyte matrix culture method to expand human chondrocytes while retaining their chondrogenic capacity. Drug discovery efforts screening a natural product library for stimulation of type II collagen has resulted in the identification of aromoline as a type II collagen stimulating compound in 3D culture of human chondrocytes. By combining in silico prediction of binding partners with transcriptomic data we were able to identify the dopamine receptor D4 as the target. This proof of concept study stimulated research into lubricin production and screening in an inflammatory model. 3D bioprinting efforts have analyzed two-part hydrogel mixtures for optimal conditions to stimulate extracellular matrix production focusing on the middle/deep zone using type II collagen as the output and the surface zone using lubricin as the output. Current efforts have been looking at the calcified cartilage/bone layer and combining the three layers. It is envisioned that this can translate into an in situ 3D bioprinting technique that could be accomplished arthroscopically. |
We have characterized primary human chondrocyte reporter cells for type II collagen and lubricin production. Extensive experience in isolating cells, producing reporters, expanding human cells while retaining chondrogenic capacity. Developed/improved biochemical assays to use fewer cells and achieve relatively high throughput. Human cartilage 3D cultures in both aggregates and sheets. | We can offer significant cartilage expertise from chondrocytes isolated from total joint replacement tissue. We would look for translation from the bench to animal models. Further translation into clinical study. Commercialization of technology. |
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Expertise in human chondrocyte culture and modification into reporter cells for 3D culture and analysis. High throughput temporal analyses of 3D cultures. Production of sheets of human cartilage. 3D bioprinting of human chondrocytes. Analysis of biomechanics and biochemical properties of tissue engineered cartilage. |
| Brigham and Women's Hospital, Harvard Medical School, Tufts University | Nitin Joshil, Li Zeng (njoshi@bwh.harvard.edu) Additional: li.zeng@tufts.edu |
Boston, MA | Dr. Nitin Joshi’s lab focuses on solving medical problems across a range of diseases, with a heavy focus on degenerative joint diseases. We are developing simple and scalable next-generation intra-articular delivery platforms for small molecule drugs, proteins and gene therapies. We have developed ultra-long acting injectables that can enable sustained release of small molecules and protein-based therapeutics for 6-12 months. In collaboration with Dr. Li Zeng from Tufts University, we have recently developed a platform that can enable the delivery of RNA therapeutics specifically to OA lesions in the cartilage, thereby maximizing gene delivery to the target cells. Our collaborator and team member - Dr. Li Zeng’s lab investigates molecular and cellular changes in the initiation and progression of osteoarthritis. By interrogating the metabolic control of developmental phases in cartilage growth, we gain important insights into bone and joint regeneration. Dr. Zeng’s lab also has multiple relevant in vitro, ex vivo and in vivo models. Our team also includes Dr. Jeffrey Karp - who brings extensive expertise in bench to bed translation of biomedical technologies. Dr Karp has co-founded ten companies that have raised over $550 million in funding with multiple products on the markets and under clinical development. |
Strengths: Extensive expertise and experience in (i) developing intra-articular drug delivery platforms for delivery of small molecules, proteins and gene therapies, (ii) bone and joint regeneration biology, (iii) in vitro, ex vivo and in vivo models of OA, and (iv) translating biomedical technologies. | We are looking for academic and/or industry partners who are involved in drug discovery for cartilage/bone regeneration and/or have novel therapeutics that would benefit from our expertise in intra-articular drug delivery, cartilage and bone regeneration biology, and in vitro, ex vivo and in vivo models. We are also looking to partner with teams with expertise in large animal models, and with experience in clinical trials related to OA. |
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Dr. Joshi’s group can offer their extensive expertise in engineering next-generation intra-articular drug delivery platforms for both small molecule and biologic therapies. The NITRO program can either leverage our proprietary technologies that we already have or can leverage our experience to build innovative platforms that can facilitate the delivery of target disease modifying agents. Dr. Zeng’s group can offer their expertise in cartilage and bone development biology and can bring to the table multiple in vitro, ex vivo and in vivo models that can support both drug discovery and the evaluation of novel drug delivery platforms and therapies. Dr. Karp brings extensive expertise in bench to bed translation of biomedical technologies, which will be critical for translating novel therapeutics developed through the NITRO program. |
| Cedars-Sinai Medical Center | Dmitriy Sheyn (Dmitriy.Sheyn@csmc.edu) | Los Angeles, CA | We have extensive clinical and translational expertise, biomanifacturing facility for clinical grade cell therapies and extensive expertise in small and large animal models. | We have expire with iPSCs differentiation towards different lineages in the MSK system, biomedical imaging institute and expire in cell tracking and imaging. | We are looking to team up with bioengineering departments and institution with strong track record in biomaterial and biopriniting capabilities to combine with cells and gene delivery systems, which we can test and further develop in our models. |
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We can offer our expertise in stem cell manipulation, gene delivery, imaging, large animal models and clinical volume and excellence of highly ranked orthopedics department. |
| Kangstem Biotech Co., Ltd | Kyounghwan Roh (khroh@kangstem.com) Additional: hkeo@kangstem.com |
Seoul, Korea | We have focused on developing ATMP* using stem cells combined with ECM**. Its therapeutic area is targeted osteoarthritis for the fundamental treatment(DMOAD) through cartilage regeneration and subchondral bone structure improvement. * Advanced Therapy Medicinal Products ** Extracellular matrix |
Strengths - We have already established a self-developed medium and master cell banking, enabling us to mass-produce hUCB-SC. Combined with ECM, it has demonstrated drastic cartilage regeneration, pain control as well as anti-inflammation from rodents to large animal study. Experience - Full spectrum experiences of the development of stem cells such as isolation, culturing, and manufacturing technology, in-vitro study, pre-clinical study as well as clinical trials since 2010. |
The current status is under phase 1 knee osteoarthritis study in Korea. To meet Nitro project phases 1 & 2 options, we look forward to finding strategic partners to expand target indications(e.g. MJ) and accelerate clinical trials in the US. |
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Phase 1 clinical data in Korea is expected to be available in Q1/Q2 2024. Additionally,we have unique platform(SELAF*) and established mater cell bank used in our extensive pre-clinical and clinical experience, which can offer the partner conducting clinical trials in the US. *SELAF: SElected cells, LArge scale and Freezing technology |
| MCRA, LLC | Erin Hagan (ehagan@mcra.com) Additional: info@mcra.com |
Washington, DC | MCRA is a leading orthopedic therapy focused CRO and advisory firm that has pioneered integrating core service offerings to support the medical product industry, including regulatory affairs, clinical study management, quality assurance, and reimbursement and market access. Our global footprint with leadership across the top 3 medical product markets (US, Europe, Japan), integrated service expertise, and deep therapeutic knowledge make us the leading partner to bring medical innovation to market around the world. | MCRA has consultants with deep technical knowledge of osteoarthritis and the mechanisms required to bring products used to treat osteoarthritis through global regulatory bodies, including the FDA. Our consultants include former regulators, scientists, and industry professionals who day-to-day support clients in designing non-clinical and clinical studies, strategizing regulatory body interactions, managing clinical trials, and working to advance medical products to market for the treatment of osteoarthritis. | We anticipate that teams may need experts in regulatory affairs, clinical study management, quality assurance, and reimbursement and market access in order to advance their products toward global commercialization. |
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MCRA, LLC can provide NITRO and Partners consulting services related to regulatory affairs, clinical study management, quality assurance, and reimbursement and market access to achieve the aims of the various technical areas and help advance novel products from the NITRO program toward global commercialization. |
| Arugula Sciences | Ramon Coronado PhD (rcoronado@signaturebiologics.com) | Irving, TX | We are a clinical-stage biotech company dedicated to the discovery, development, and commercialization of advanced therapeutics that leverage the biological properties of human perinatal tissues and cells. All our efforts are made to support patients and help fulfill their unmet clinical needs. | We have experience in FDA clinical trials in Osteoarthritis and ex-US clinical experiences using Umbilical Cord Mesenchymal Stem Cells (MSCs) for several other indications. | In vitro and animal OA models to test our products |
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Cell and biologics cGMP manufacturing |
| Florida Atlantic University | Yunqing Kang (kangy@fau.edu) | Boca Raton, FL | Our focus areas are in bone tissue regeneration. We develop injectable hydrogel with ROS-scavenging nanoparticles to modulate the microenvironment of bone/cartilage microenvironment. The hydrogel is derived from the native bone matrix. The nanoparticle has hollow structure which can load growth factors or stimulators. This composite system enable us to effectively regenerate bone defect or treat osteoarthritis. | We have rich experience in bone biomaterials, bone scaffolds, bone hydrogels. | We are looking for orthopedic surgeon, bone biologist. |
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Biomaterial scientists, bioengineer. |
| bit.bio Ltd | Thomas Moreau (thomas.moreau@bit.bio) Additional: manos.metzakopian@bit.bio |
Cambridge, U.K. | bit.bio is a leading synthetic biology company focussed on scalable and consistent manufacture of human cells for cell therapy and research applications. Our opti-ox cell reprogramming technology enables deterministic reprogramming of hiPSCs into a wide range of cell types, resulting in unmatched consistency (>1% variation, see recent press release) and scale (trillions of cells). It leverages genomic safe harbour sites to control the expression of lineage-relevant transcription factors in hiPSCs. bit.bio’s validated end-to-end platform has industrialised the development and manufacture of new cell types and have the broadest pipeline of cell types of any cell therapy company. • Cell identity-inducing transcription factor combinations are identified in large-scale functional TF screens in combination with advanced data science and ML approaches. • Our Cell Type Development, Manufacturing Science and Technology teams generate robust and scalable manufacturing protocols and have proven their capabilities in >15 cell types across all three germ layers • Our CMC team has world leading expertise in GMP compliant manufacture of clinical products • We have a deep synbio tech stack, including hypoimmune technology and death switches We are backed by a team of world-leading stem cell scientists, including Marius Wernig (Stanford), Roger Pedersen (Stanford), as well as industry experts, including Loic Vincent (Affini-T). |
Our organisation has industrialised the generation and manufacture of hiPSC-derived cell types, with an ability to deliver a new cell type product in less than 24 months. We have deep CMC and manufacturing expertise, including GMP as well as translational medicine expertise. bit.bio has an internal pipeline of cell therapy programs in the immune, metabolic, and liver space. |
We would like to contribute our capabilities to generate immune cells and cells aiming at cell replacement to a consortium with expertise in tissue engineering, preclinical AO models, drug application. |
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bit.bio can generate highly efficient and reproducible protocols for the differentiation of hiPSCs into any cell type. Our protocols are single step and use fully defined media conditions. In the context of the call we propose the development of chondrocytes +/- osteocytes, and /or CAR-NK or macrophages targeting the removal of senescent cells (a driver of OA). We further propose to integrate universal cell / hypo immune technology and death switches to enable and off the shelf cell replacement paradigm. |
| QLEDCures, LLC & University of Central Florida | Yajie Dong (Yajie.Dong@qledcures.com) Additional: Yajie.Dong@ucf.edu |
Orlando, FL | We develop flexible quantum dot light emitting diode (fQLED) devices for non-invasive phototherapy (including photodynamic therapy, PDT and photobiomodulations, PBM). | We pioneered using flexible QLED for PDT and PBM applications. QLEDCures has received STTR funding supports from DARPA, DoD Army and NSF for related developments. | We are looking for medical experts on arthritis drugs that can be delivered through microneedle systems. |
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Our flexible QLED devices can be the base substrate of microneedle patches for transdermal delivery of arthritis drugs (https://doi.org/10.3390/pharmaceutics14081736). QLED light can stimulate controlled drug delivery with microneedles (https://doi.org/10.1016/j.mattod.2021.03.012) and could stimulate bone/cartilage regeneration through PBM effect. |
| Asante Bio | Michael Francis (mfrancis@asantebio.com) Additional: admin@asantebio.com |
Tampa FL | We are driving next-generation orthobiologics, including advanced biomaterials, biomanufacturing, and non-viral gene therapy approaches to treating orthopedic and sports medicine challenges. Our targets include osteoarthritis, rotator cuff regeneration, volumetric muscle loss, and regenerating composite tissues following complex traumas, including bone, muscle, ligament, and tendon regeneration. | In the spirit of "it takes a village," Asante Bio has a deep surgeon/clinician network, US military network, and academic inroads to create the needed technical, commercial, and regulatory expertise to drive high-impact technologies into clinical use. | We seek outstanding partners across the public, private, and government sectors looking to transform healthcare for all. |
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We offer NITRO a veteran research and product development team with deep experience and success driving innovations from concept to clinic (the PI previously led a large DARPA program to clinical use across multiple orthobiologic indications). |
| BioMagnetic Sciences | Scott Munsterman (smunsterman@novo-pulse.com) Additional: ajafaar@novo-pulse.com |
Eden Prairie, MN | The NovoPulse® device is a breakthrough proprietary transcutaneous Deep electrical joint stimulation device platform - a novel non-opioid, non-pharmacological product for chronic pain management and the treatment of osteoarthritis (OA). It is an FDA-listed class I, 510(K) exempt physical medicine therapeutic device. Our five issued patents cover “Thermally assisted pulsed electro-magnetic field stimulation device and method for treatment of osteoarthritis.” The unique novelty of the inventions is a combination of electrical stimulation and thermal stimulation, which for the first time successfully addresses the two underlying causes of OA: inflammation and apoptosis of cartilage cells. | We are a pre-revenue stage company entering the market. CMS (Centers for Medicare & Medicaid Services) has assigned reimbursement to HCPCS Level II code E0762 “Transcutaneous electrical joint stimulation device system, includes all accessories” to describe NovoPulse®. | We want to partner to collect clinical outcomes for both pain management and cartilage regeneration with our device. |
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In NovoPulse® MKX-1, a unique multicoil system is designed to generate appropriate amplitude Deep Electric Field and deliver it to intervertebral discs, facet, and extremity joints with adequate duration, amplitude, orientation, and distribution as the magnetic field serves as a carrier of the electric field into the treatment zone. This action of Deep Electric Field Stimulation (EFS) is similar to that of NSAIDs but without the latter’s detrimental side effects. Moreover, restoration of cartilage caused by EFS leads to long-term pain relief that holds for months after treatment and is an exclusive feature of EFS therapy. In addition to the Deep Electric Field Stimulation, NovoPulse® provides Thermal Stimulation, which is synergistically combined with Electric Field Stimulation. Thermal Stimulation of the joint increases blood flow around the joint, promotes diffusion of nutrients in and the waste product out of the joint. Current research indicates pain reduction and promotion of cartilage tissue regeneration in osteoarthritis. |
| EpiBone, Inc. | Nina Tandon, Co-Founder & CEO (nina@epibone.com) Additional: allegra@epibone.com |
Jersey City, NJ | EpiBone is an innovative clinical-stage organization dedicated to the field of regenerative medicine. Leveraging the synergistic power of stem cells, biomimicry, and advanced 3D fabrication techniques, we are at the forefront of developing innovative products for bone and cartilage repair. Our lead product, a living, autologous, and anatomically precise 3D bone graft, is currently undergoing a Phase I/IIa clinical trial, slated for completion in August 2023. Encouragingly, all patients have undergone successful implantation, with exceptional integration and healing progress observed as anticipated. Furthermore, our pipeline includes an allogeneic osteochondral plug with substantial market potential, and an allogeneic injectable cartilage filler supported by the Department of Defense. | EpiBone's strengths and experience are founded on over 40 years of groundbreaking research led by leaders of the field of tissue engineering: Dr. Robert Langer and Dr. Gordana Vunjak-Novakovic. We possess extensive capabilities, including the manufacturing of both allogeneic and autologous tissues within our state-of-the-art human-grade cGMP facility. Our robust IP portfolio encompasses crucial aspects of the design, manufacture, surgical implantation, and shipping of living bone and cartilage grafts. Additionally, our proprietary osteogenic and chondrogenic cell culture media cocktails provide optimal conditions for nurturing and guiding the growth and differentiation of stem cells. What sets us apart is our remarkable success in translating scientific discoveries from the laboratory to clinical trials, exemplifying our ability to bridge the gap between research and tangible medical solutions. | As we seek potential teaming partners, we have distinct requirements based on our research areas. For TA1 and TA2, we are seeking partners who can lend their expertise in cell sourcing, arthroscopic delivery, injectable delivery, and working with extracellular vesicles and OA-targeted liposomes. In the realm of TA3, our partnership needs are more extensive. We are seeking collaborators with capabilities in rapid cell processing and allogeneic cell sourcing. Additionally, we aim to join forces with partners experienced in graft design, graft maturation (including bioreactor design), and graft fabricationincluding 3D fabrication and 3D printed bone. Finally, we are also interested in meeting with partners with experience in implantation of osteochondral grafts, with regards to fixation, surgery, delivery and joint mechanical testing. |
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With over two decades of experience in tissue engineering, our team is on the forefront of pioneering the next generation of tissue repair technologies. As the first and only biotechnology company to secure FDA clearance for human trials of a stem cell-based tissue product, we demonstrate our commitment to innovation and regulatory compliance. Comprising top-tier professionals from renowned institutions, our 32-person team possesses expertise in engineering autologous anatomical bone, allogeneic osteochondral grafts, and injectable cell-based tissues for cartilage repair. We have a comprehensive IP portfolio, including scalable bioreactor systems, advanced delivery tools, and tissue decellularization, as well as proprietary culture media cocktails. Additionally, we bring valuable insights from two successful translation programs, including the engineering of an osteochondral plug nearing FDA approval expected within the next two months) and a Phase I/IIa clinical trial for autologous bone grafts demonstrating excellent safety and integration outcomes. |
| Drexel University | Lin Han (lh535@drexel.edu) Additional: cak46@drexel.edu |
Philadelphia, PA | Our lab studies the extracellular matrix (ECM) in the biomechanics and mechanobiology of soft musculoskeletal tissues using genetically modified murine models. Current focuses are on the roles of regulatory proteoglycans (decorin, biglycan) and collagens (types III, V, XI) in the development, remodeling and regeneration of cartilage and meniscus. We are particularly interested in these molecules’ modulation of the dynamic cell-matrix cross-talk at the pericellular matrix (PCM) interface, and the development of novel ECM molecule-based biomaterials to target disease progression and regeneration. | We have extensive expertise in nano/micromechanics of healthy, disease and regenerative tissues, small animal OA models, cell mechanotransduction, and biochemical/biophysical characterization of matrix molecules. | We are looking for strategic partnerships with biotech and pharma companies to assist with the translation and advancement of our ECM-based therapeutics. |
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Our lab studies the extracellular matrix (ECM) in the biomechanics and mechanobiology of soft musculoskeletal tissues using genetically modified murine models. Current focuses are on the roles of regulatory proteoglycans (decorin, biglycan) and collagens (types III, V, XI) in the development, remodeling and regeneration of cartilage and meniscus. We are particularly interested in these molecules' modulation of the dynamic cell-matrix cross-talk at the immediate cell niche, i.e., the pericellular matrix (PCM), as well as the development of novel ECM molecule-based biomaterials to target disease progression and regeneration. |