MEDIPOST Doses First US Patient in Umbilical Cord Stem Cell Therapy for Knee Osteoarthritis Phase 3

Key Points

• MEDIPOST has dosed the first U.S. patient in a Phase 3 trial of an investigational mesenchymal stem cell (MSC) therapy for knee osteoarthritis.
• The FDA has agreed that this single U.S. pivotal study, along with prior Phase 3 data from South Korea and Japan and Korean real-world evidence, could support a planned BLA filing.
• The trial is enrolling adults ages 18 to 75 with knee cartilage lesions and osteoarthritis to evaluate efficacy in symptomatic cartilage defects.

MEDIPOST, a Korean biotech company, has treated the first U.S. participant in its Phase 3 clinical trial of an investigational mesenchymal stem cell (MSC) therapy for symptomatic cartilage defects in adults with knee osteoarthritis. The therapy, Cartistem, is allogeneic (donor derived) and sourced from umbilical cord blood. The first procedure was performed by Dr. Justin Newman at Orthopedic Centers of Colorado.

Cartistem is already approved in Korea, and met all its primary endpoints in its Japanese Phase 3 this year. Next up, United States….

The FDA granted the company fast-track designation, agreeing that if it passes this US trial, supported by prior Phase 3 trials in South Korea and Japan and real-world evidence from Korea, it can serve as the basis for MEDIPOST’s planned biologics license application.

What the Study Is Evaluating

Knee osteoarthritis affects more than 32 million adults. MEDIPOST’s Phase 3 study is enrolling adults ages 18 to 75 with knee cartilage lesions and osteoarthritis. The trial is designed to evaluate the clinical efficacy of the company’s MSC therapy and its potential benefit in patients with symptomatic cartilage defects related to knee osteoarthritis.

Prior Clinical Background

MEDIPOST’s program builds on earlier studies conducted in Asia. The company’s Cartistem has been approved in South Korea since 2012, and more than 36,000 patients there have received the product.

“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.”

“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.

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