Duke Health researchers advance osteoarthritis therapy toward clinical trials

Craig T. Albanese, CEO
Craig T. Albanese, CEO
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Duke Health announced on Apr. 6 that its research team has reached a key milestone in developing new treatments for osteoarthritis, a condition affecting more than 32 million Americans.

The announcement is significant because current treatments for osteoarthritis often focus only on managing pain or require joint replacement surgery. The new approach aims to help the body repair damaged joints directly, which could change how the disease is treated.

Project lead Benjamin A. Alman, M.D., chair of the Department of Orthopaedic Surgery at Duke University School of Medicine, said, “This milestone brings us closer to a future where we can treat the root cause of osteoarthritis, not just the symptoms.” Alman added that their long-term goal is to help people remain active and independent longer.

The Duke-led team works with researchers from UCLA, Boston Children’s Hospital and Harvard University as part of the BUD NextGenRegen therapeutic program. They have completed preclinical goals in animal models by using combinations of pharmacologic agents that restored joint tissue and reduced pain markers after treatment. These efforts were supported by an initial $13 million award through the Advanced Research Projects Agency for Health (ARPA-H) NITRO program in 2024.

Clinical lead Thomas Kremen, M.D., an orthopaedic surgeon at UCLA’s David Geffen School of Medicine, said: “Yes, the goals are ambitious. But we have made incredible progress so far. With the right team, resources, and shared dedication, we can successfully develop this technology into a viable treatment.” April Craft, Ph.D., assistant professor at Boston Children’s Hospital/Harvard Medical School also commented on teamwork: “Our team, our institutions, the ARPA-H NITRO program, healthcare providers, and patient communities from various regions across the country all provided valuable input to ensure success.”

The next phase will include advanced safety testing and preparation for regulatory review before moving into human clinical trials within 18 to 24 months if progress continues as planned. Patent applications have been filed covering these formulations and plans are underway to form a spinout company for further development.

Osteoarthritis most commonly affects knees—accounting for over 80% of cases—and leads to nearly 800,000 knee replacement surgeries each year in America among those aged 45 or older. Located in Durham since its founding in 1925, Duke University Hospital admitted over 41,000 patients during calendar year 2022.



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