Medipost's Cartistem Receives IND Approval for Phase 3 Clinical Trial in the U.S.

Full-scale push to validate cartilage-regenerating "DMOAD"

Medipost's knee osteoarthritis treatment Cartistem is entering Phase 3 clinical trials in the United States.

Medipost announced on the 4th that the Phase 3 clinical trial protocol for Cartistem, an umbilical cord blood-derived allogeneic mesenchymal stem cell therapy, has been approved by the U.S. Food and Drug Administration. With this approval, Medipost is initiating the final clinical stage in the United States, the world's largest pharmaceutical market.

MediPost logo image. MediPost

The U.S. Phase 3 trial has been designed as a randomized, double-blind, multinational study. It will evaluate the efficacy and safety over two years after surgery by comparing a Cartistem treatment group with a control group undergoing arthroscopic debridement in patients with moderate to severe knee osteoarthritis. The company plans to recruit several hundred patients at approximately 60 clinical trial sites across the United States and Canada. Medipost has completed preparations to begin the trial, aiming to enroll the first patient in the first quarter of 2026.

The company plans to use this trial to demonstrate the clinical efficacy and safety of Cartistem as a disease-modifying osteoarthritis drug (DMOAD) based on cartilage regeneration. According to the company, Cartistem has been commercialized in Korea since it received marketing approval in 2012, and long-term real-world treatment data have confirmed its safety and therapeutic effect.

In parallel with the U.S. Phase 3 trial, Medipost is also pursuing business development collaborations with global pharmaceutical companies. The company is reviewing various partnership models for key regions, including the United States and China, with the aim of expanding global commercialization opportunities.

Meanwhile, in Japan, Medipost has completed a Phase 3 clinical trial of Cartistem and is preparing the final clinical study report. The company plans to announce the clinical results in the second quarter of 2026, then apply for marketing approval in the second half of the same year, with the goal of obtaining approval in 2027. In December last year, Medipost signed an exclusive distribution agreement for Cartistem in Japan with Teikoku Seiyaku and secured an upfront payment and regulatory milestones.

This content was produced with the assistance of AI translation services.