MediPost announced on the 22nd that it has successfully completed the dosing phase for the Phase 3 clinical trial of Cartistem, its stem cell-based treatment for knee osteoarthritis, in Japan.

Cartistem, approved by Korea’s Ministry of Food and Drug Safety (MFDS) in 2012, is a treatment derived from allogeneic umbilical cord mesenchymal stem cells. 

MediPost explained that Cartistem is the first advanced biopharmaceutical from Korea to directly advance to Phase 3 clinical trials in Japan, bypassing Phase 1 and 2 trials. This was made possible due to the recognition of domestic clinical trial results by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare.

The Phase 3 trial in Japan, which began in 2023, involved 130 patients with moderate to severe knee osteoarthritis (K&L Grade 2–3) at 13 medical institutions across the country. The study used an open-label, randomized, and active-controlled design, with hyaluronic acid sodium (HA) injections serving as the comparator.

According to MediPost, the trial is assessing improvements in joint function, pain relief, and regeneration of damaged knee cartilage over a one-year (52-week) follow-up period. Approximately 25% of participants have already completed their one-year follow-up evaluations.

A representative from MediPost stated, "We are currently analyzing real-world evidence (RWE) from around 1,000 Cartistem-treated patients in Korea. These findings will serve as critical data to support future applications for insurance reimbursement and regulatory approval in Japan."