Cambridge, Mass. — MEDIPOST Inc. said it has treated the first U.S. participant in its Phase III clinical trial evaluating an investigational mesenchymal stem cell therapy for symptomatic cartilage defects in adults with knee osteoarthritis.
MEDIPOST, a biotechnology company developing allogeneic, umbilical cord blood-derived stem cell therapies for inflammation-driven degenerative diseases, said the milestone expands the clinical investigation of its stem cell therapy in the United States.
The company said the U.S. Food and Drug Administration has agreed that the single pivotal study, supported by confirmatory evidence from prior Phase 3 trials in South Korea and Japan, along with Korean real-world evidence, can serve as the basis for MEDIPOST’s planned U.S. biologics license application filing.
The first U.S. procedure was performed by Dr. Justin Newman at Orthopedic Centers of Colorado.
“Treating the first U.S. adult participant in this Phase III trial is a defining moment for the field of regenerative medicine,” stated Brian Cole, MD, MBA, Head of the Cartilage Research and Restoration Center at Rush University Medical Center. “This investigational MSC therapy is being studied for its role in knee osteoarthritis, where a gap exists between non-interventional palliative care and total knee replacement. This research gives us a meaningful opportunity to investigate whether a regenerative approach can help address it.”
Knee osteoarthritis affects more than 32 million adults. MEDIPOST said the Phase III trial is enrolling adults ages 18 to 75 with knee cartilage lesions and osteoarthritis. The study is designed to evaluate the clinical efficacy of the investigational MSC therapy and its potential benefits in adults with symptomatic cartilage defects due to knee osteoarthritis.
“Earlier clinical studies provided important data that helped guide the development of this Phase III trial,” said Andreas Gomoll, Attending Orthopedic Surgeon at the Hospital for Special Surgery (HSS) in New York. “This Phase III trial is designed to demonstrate efficacy of a MSC therapy in adults with knee osteoarthritis; this is a significant step forward in generating the definitive evidence that could provide patients with better treatment options.”
“Treating the first participant in this trial is a milestone moment, not just for the science but for the osteoarthritis patients I see every day with pain and mobility challenges caused by cartilage defects,” said Dr. Justin Newman of Orthopedic Centers of Colorado. “I look forward to learning more about the outcomes observed in those participating in this trial.”
