MEDIPOST Treats First U.S. Participant in Phase III Stem Cell Therapy Trial for Knee Osteoarthritis

MEDIPOST Inc. announced the treatment of the first U.S. participant in its Phase III clinical trial evaluating an investigational mesenchymal stem cell (MSC) therapy to treat symptomatic cartilage defects in adults with knee osteoarthritis. The FDA has agreed that this single pivotal study, supported by confirmatory evidence from prior Phase 3 trials in South Korea and Japan together with Korean real-world evidence, can serve as the basis for MEDIPOST's planned U.S. Biologics License Application (BLA) filing.

The procedure was performed by Dr. Justin Newman at Orthopedic Centers of Colorado. The Phase III trial is currently enrolling adults between the ages of 18 and 75 years 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.

Knee osteoarthritis affects more than 32 million adults. "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," stated the Head of the Cartilage Research and Restoration Center at Rush University Medical Center. An attending orthopedic surgeon at the Hospital for Special Surgery in New York noted that earlier clinical studies provided important data that helped guide the development of this Phase III trial, which is designed to demonstrate efficacy of an MSC therapy in adults with knee osteoarthritis.

MEDIPOST had previously submitted an investigational new drug (IND) amendment to the FDA to initiate the Phase III trial, with enrollment planned to begin in the first half of 2026. In January 2026, MEDIPOST's parent company closed a $140 million funding round led by Skylake Equity Partners and Crescendo Equity Partners, with participation from Korea's growth equity fund. The investment is intended to support the expansion of scientific and operational capacities, infrastructure development, and scaling of manufacturing processes for the Phase III trial.

Founded in 2000, MEDIPOST is a global cell therapy company that commercialized CARTISTEM® in South Korea in 2012, the world's first approved allogeneic human umbilical cord blood-derived mesenchymal stem cell therapy for knee osteoarthritis. More than 36,000 patients have received CARTISTEM® in South Korea since its launch. The therapy described in this trial is an investigational product and has not been approved by the FDA; its clinical benefit has not yet been established.