The University of Miami Miller School of Medicine has received FDA authorization to launch a first-of-its-kind knee osteoarthritis trial that delivers stem cells through the arteries supplying the knee.
The FDA cleared the study to proceed under an investigational new drug application, the Miami-based medical school said in an Oct. 19 news release. The trial will test safety and feasibility in patients with mild to moderate knee osteoarthritis whose symptoms persist despite nonsurgical treatment.
Most prior stem cell research for osteoarthritis has involved injecting cells into the joint. In this trial, interventional radiologists will use image-guided techniques to route umbilical cord-derived cells through small arteries feeding the inflamed joint lining. The approach builds on the team’s work in genicular artery embolization.
Principal investigator Bedros Taslakian, MD, said the study targets patients “who still have significant symptoms despite available therapies” but are not ready for joint replacement.
Enrollment has not yet begun, pending additional regulatory and operational milestones.
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