Collaboration Supports ARPA-H-Funded Program to Develop Stem Cell Therapy Implants for Phase I Clinical Trial Under FDA Oversight

PRINCETON, N.J., June 1, 2026 /PRNewswire/ — Made Scientific, Inc., a leading U.S.-based clinical- and commercial-stage cell therapy contract development and manufacturing organization (CDMO), today announced it has been selected as manufacturer for NOVAKnee, a first-in-class 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. NITRO is led by ARPA-H Program Manager Dr. Ross Uhrich.

Made Scientific will provide technology transfer, analytical and process development, and GMP clinical manufacturing services of drug substances and drug products of the combination NOVAKnee-T and NOVAKnee-L implants for human use in a Phase 1 clinical trial in the US, anticipated to begin in 2028.

NOVAKnee is designed to replace traditional metal and plastic knee implants with a living biologic alternative using a biodegradable scaffold seeded with bone and cartilage progenitor cells to restore joint function through biological tissue regeneration, rather than mechanical substitution.

“This program reflects a bold shift in orthopedic care by replacing a traditional implant with a living, cell-based product,” said Syed T. Husain, Chairman and CEO of Made Scientific. “We are committed to delivering the manufacturing excellence required to advance NOVAKnee from the laboratory to patients.”

“The NOVAKnee program aims to fundamentally change how we approach joint replacement, and a manufacturing partner with deep cell therapy expertise is essential to that goal,” said Clark Hung, PhD, Vice Chair and Professor of Biomedical Engineering at Columbia University. “We look forward to working with Made Scientific as we advance NOVAKnee-L and NOVAKnee-T toward a Phase 1 clinical trial.”

The ARPA-H NITRO program funds Columbia University’s NOVAJoint initiative to accelerate next-generation biologic solutions for joint replacement. This collaboration reinforces Made Scientific’s role as a trusted and reliable manufacturing partner for advanced cell therapy programs moving from academic innovation into clinical development, delivering on its mission to defy limits and deliver results.

About Made Scientific
Made Scientific is a U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors. For more information, visit madescientific.com.

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SOURCE Made Scientific, Inc.