Made Scientific Selected to Manufacture Columbia University’s NOVAKnee, a 3D Printed Knee Replacement Made of Stem Cells and Scaffolds
The Living Knee project is hoping to replace traditional knee replacements, expected to begin Phase 1 trials around 2028.
Key Points
- Columbia University is working on a biodegradable “living knee” that aims to replace knee replacements with a 3D-printed knee made of scaffolding and stem cells.
- Made Scientific has recently been selected as the CDMO partner to manufacture this, and Phase 1 trials are expected around 2028.
Columbia University is developing what it calls the “Living-Knee”, or NOVAKnee, which aims to replace traditional knee replacements. Instead of a plastic or metal implant, the university is developing a 3D-printed knee replacement made from biodegradable scaffolding material infused with stem cells. It’s implanted similar to a traditional knee replacement; however, this version is designed to regenerate the joint’s natural cartilage and bone tissue as the scaffold disappears.
The implant contains combinations of biomaterials to make femoral- and tibial-shaped implants, sized to the patient’s knee. Then it is seeded with cartilage and bone cells derived from stem cells, either from the patient’s own body (lipoaspirate from the abdomen) or from adult induced pluripotent stem cells (iPSCs).
Made Scientific, a New Jersey-based CDMO, has now been selected as the manufacturing partner for this project. It’s being developed by researchers at Columbia University’s School of Engineering and Vagelos College of Physicians and Surgeons under the Advanced Research Projects Agency for Health (ARPA-H) Novel Innovations for Tissue Regeneration in Osteoarthritis, or NITRO, program.
Made Scientific will provide technology transfer, analytical and process development, and GMP clinical manufacturing for the NOVAKnee-T and NOVAKnee-L combination implants. These products are being prepared for human use in a Phase 1 clinical trial in the U.S., anticipated to begin in 2028.
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