New Research Brings Joint Repair Closer for Millions With Osteoarthritis
Federal program advances promising therapies that aim to regenerate damaged joints
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DURHAM, N.C. — Osteoarthritis affects more than 32 million Americans, making it one of the leading causes of chronic pain, disability, and loss of mobility in the United States.
For many people, treatment options are limited to managing pain with medications or repeated injections, and in severe cases, replacing the joint entirely through surgery.
A team of researchers led by Duke Health have now reached a major milestone in a national effort to develop a new kind of treatment aimed at helping the body repair damaged joints at the source, bringing the approach closer to first‑in‑human clinical trials and accelerating momentum toward a potential commercially availble therapy.
“This milestone brings us closer to a future where we can treat the root cause of osteoarthritis, not just the symptoms,” said Benjamin A. Alman, M.D., project lead and chair of the Department of Orthopaedic Surgery at Duke University School of Medicine. “Our long-term goal is to help people stay active, independent, and mobile for longer.”
Duke serves as the primary site for the project, working closely with researchers at UCLA, Boston Children’s Hospital and Harvard University.
The progress is driven by the BUD NextGenRegen therapeutic program, a collaboration uniting regenerative medicine experts from various institutions. Through this effort, the team has successfully achieved the preclinical goals associated with the first phase of the Advanced Research Projects Agency for Health (ARPA-H) NITRO (Novel Innovations for Tissue Regeneration in Osteoarthritis) funding for the project, supported by an initial $13M award in 2024. NITRO is led by ARPA-H Program Manager, Ross Uhrich, DMD, MBA.
This team has been chosen to move forward to the next development phase, with the possibility of securing up to $12.5M in additional funding. They will now prepare to advance to first-in-human clinical trials, gaining momentum toward a potential new treatment.
They are developing three experimental treatments designed to activate the body’s natural repair processes in cartilage and the underlying bone, which break down in osteoarthritis.
In animal models, scientists tested carefully designed combinations of pharmacologic agents to activate joint repair. The experimental drug treatments restored joint tissue to near‑normal levels and significantly reduced pain markers for long periods after treatment.
Although the therapies have not yet been tested in humans, the results point to a promising new way to address osteoarthritis by targeting the damage that drives pain and loss of function.
Based on these findings, the team has been selected to move forward to the next phase of development work, which will focus on advanced safety testing, dosing studies, and preparation for the new drug application stage with the U.S. Food and Drug Administration before any potential treatment can move into clinical trials.
“This is where the science must meet the highest standards,” Alman said. “Every step now is about safety, rigor, and doing this the right way.”
“Yes, the goals are ambitious,” said project clinical lead Thomas Kremen, M.D., an orthopaedic surgeon at UCLA’s David Geffen School of Medicine. “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.”
“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,” said April Craft, Ph.D., assistant professor of Orthopaedic Surgery at Boston Children’s Hospital/Harvard Medical School, who emphasized the teamwork behind the scenes.
If progress continues as planned, the team expects to be ready for first‑in‑human trials within the next 18 to 24 months. Patent applications have been filed covering the new formulations, and a spinout company will be formed to prepare for further clinical development and commercialization.
“Our goal is simple,” Alman said. “To give people with osteoarthritis a chance to keep moving, stay active, and avoid surgery whenever possible.”
To put the potential impact in context, knee osteoarthritis accounts for more than 80% of all osteoarthritis cases, affecting at least 17 million Americans ages 45 and older. The disease is also the leading cause of total knee replacement surgery, with nearly 800,000 procedures performed each year in the United States.