A Duke Health-led team, in collaboration with UCLA, Boston Children’s Hospital, and Harvard, has achieved a major preclinical milestone in developing a regenerative therapy for osteoarthritis that targets repair at the source rather than just addressing symptoms.

A multi-institution collaboration among the University of Colorado Boulder, University of Colorado Anschutz, and Colorado State University has developed regenerative therapies that prompt repair of aging or damaged joints in weeks, based on animal studies.

The Colorado-based collaboration aims to repair damaged joints and cartilage to treat osteoarthritis using experimental regenerative therapies.

Next steps include rigorous safety testing, dosing studies, and preparation for FDA drug application, with first-in-human trials potentially in 18 to 24 months if progress continues.

If progress remains on track, first-in-human trials could be feasible within 18–24 months, contingent on safety and regulatory milestones.

Plans include patent filings and the formation of a spinout company to support later development and commercialization alongside advancing toward human trials.

Dr. Benjamin A. Alman leads the effort, emphasizing safety and rigorous development as guiding principles throughout the process.

Osteoarthritis affects roughly one in six people over 30 worldwide, with current options limited to pain management or joint replacement, highlighting the potential impact of these therapies.

Proposed treatments include a one-time intra-articular regenerative injection and a biomaterial-based repair system designed to recruit the body’s own cells for cartilage restoration.

Therapies feature a single regenerative joint injection using an FDA-approved drug with a patented particle delivery system, plus a separate cocktail of engineered proteins injected arthroscopically to recruit progenitor cells for cartilage and bone repair.

ARPA-H’s NITRO program will move the project into the next phase, potentially providing up to $33.5 million in total funding, with a possible additional $12.5 million for further development.

The BUD NextGenRegen program, a collaboration among Duke, UCLA, Boston Children’s Hospital, and Harvard, is funded in part by ARPA-H and began with an initial $13 million award in 2024, with potential for additional support up to $12.5 million.