MediPost's "Knee Osteoarthritis Treatment 'Cartistem' Enters Phase 3 Clinical Trial in Japan"

Safety and Efficacy Evaluation Begins for 130 Patients with Mild to Moderate Symptoms

Exterior view of Medipost headquarters.

[Asia Economy Reporter Lee Gwan-ju] Medipost announced on the 25th that its knee osteoarthritis treatment 'Cartistem' has officially entered Phase 3 clinical trials in Japan.

Medipost received approval for Cartistem's Phase 3 clinical trial from the Japanese Ministry of Health, Labour and Welfare in February last year. Cartistem became the first regenerative medicine in Korea to skip Phase 1 and 2 trials and proceed directly to Phase 3, an unusual case recognized based on domestic clinical results.

This clinical trial will be conducted on a total of 130 patients with mild to moderate (K&L grade 2-3) knee osteoarthritis. Patients will be divided into two groups: one group will receive Cartistem, and the control group will receive hyaluronic acid injections. After 52 weeks of follow-up, joint function improvement, pain relief, and regeneration of damaged knee cartilage will be compared and analyzed.

The Phase 2 clinical trial of Cartistem combined with high tibial osteotomy (HTO), which had been temporarily suspended due to COVID-19, has also resumed. This resumed Phase 2 trial will evaluate efficacy and safety by comparing a control group of 50 patients with mild to severe (K&L grade 2-4) knee osteoarthritis who underwent HTO alone, and a test group who received both Cartistem and HTO.

A Medipost official stated, “Although the Japanese clinical trial was significantly delayed due to COVID-19, since safety and efficacy were recognized in Japan allowing us to skip Phases 1 and 2 and proceed directly to Phase 3, the trial is expected to progress smoothly. We anticipate that successfully completing the Japanese trial will elevate the status of K-bio as the first stem cell treatment for knee osteoarthritis in Japan.”

Meanwhile, Medipost plans to accelerate its entry into the U.S., the world's largest knee osteoarthritis market, following Japan, as it has been allowed to skip Phase 2 and proceed directly to Phase 3 in the U.S. based on recognition of domestic clinical data.

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