- Made Scientific has been selected to provide manufacturing services for NOVAKnee, a living biologic total knee replacement being developed by Columbia University under the ARPA-H NITRO program.
- The cell therapy CDMO will provide technology transfer, process development, analytical development, and GMP manufacturing support for a Phase 1 clinical trial in the United States anticipated to begin in 2028.
Made Scientific, Inc. has been selected as the manufacturing partner for NOVAKnee, a living biologic total knee replacement 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 (NITRO) program.
Under the agreement, the cell therapy CDMO will provide technology transfer, analytical development, process development, and GMP clinical manufacturing services for the NOVAKnee-T and NOVAKnee-L combination implants. The manufacturing activities will support a Phase 1 clinical trial in the United States that is anticipated to begin in 2028.
NOVAKnee is being developed as an alternative to conventional metal and plastic knee implants. According to the announcement, the product uses a biodegradable scaffold seeded with bone and cartilage progenitor cells and is intended to restore joint function through biological tissue regeneration.
“This program reflects a bold shift in orthopedic care by replacing a traditional implant with a living, cell-based product. We are committed to delivering the manufacturing excellence required to advance NOVAKnee from the laboratory to patients.”
Syed T. Husain, Chairman and CEO of Made Scientific
The NOVAJoint initiative is funded through the ARPA-H NITRO program and is intended to accelerate the development of biologic solutions for joint replacement. Made Scientific said the collaboration supports the advancement of academic cell therapy innovations into clinical development through its contract manufacturing capabilities.
