· Targeting 130 patients with mild and moderate knee osteoarthritis, CARTISTEM^®’s safety and efficacy to be evaluated through a 52-week follow-up observation period after administration.
· To accelerate Phase 3 in Japan and prepare for commercialization, local medical staff training and a series of symposia are expected to yield enhanced staff expertise and pre-marketing effects.

MEDIPOST’s flagship product for knee osteoarthritis (OA) treatment, CARTISTEM^®, has officially entered Phase 3 clinical trial in Japan.

MEDIPOST (CEO: Oh Won-il) announced on the 16th the successful dosing of CARTISTEM^® to the first OA patient for its Phase 3 clinical trial in Japan, after overcoming initial delays caused by COVID-19. CARTISTEM^® from South Korea is the first advanced biopharmaceutical to directly advance to Phase 3 clinical trials, bypassing Phase 1 and 2, owing to its internationally acknowledged domestic clinical results .

This Phase 3 trial is set to involve a total of 130 patients diagnosed with mild to moderate (K&L grades 2 to 3) knee OA. Patients are structured into two groups, one group to receive CARTISTEM^® treatment, and the other to receive hyaluronic acid injections as a control (comparator). The trial includes a 52-week post-surgery follow-up observation period, during which improvements in joint function, pain relief, and regeneration of damaged knee cartilage will be analyzed and compared.

Recognizing the importance of specialized surgical expertise and know-hows associated with CARTISTEM^®, MEDIPOST is now actively engaged in the Transfer of its extensive domestic surgical expertise to the Japanese clinical principal investigators involved in the trial in Japan. These investigators are simultaneously undergoing comprehensive training programs, which includes attendance to CARTISTEM^® symposia in Japan, direct observation of CARTISTEM^® surgical procedures and first-hand engagement in technical trainings in partnership with the Korean medical leaders. These programs are designed to ensure the acquisition of proper and consistent surgical techniques specific to CARTISTEM^®, aiming to facilitate a successful clinical trial and pave the way for future commercialization.

CARTISTEM^® is the world‘s first allogeneic umbilical cord blood-derived stem cell therapy. Unlike traditional arthritis treatments that mainly focus on pain relief and temporary functional improvements, CARTISTEM^® had approved its efficacy by offerring not only suppression of inflammation but also a fundamental solution by promoting regeneration the damaged cartilage tissue to its natural state. With over 25,000 surgical cases and cumulative sales exceeding KRW 100 billion, CARTISTEM^® has a proven record of safety, outstanding long-term efficacy, and cost-effectiveness as a leading knee osteoarthritis treatment.

A MEDIPOST representative stated, “With the loosening local COVID-19 containment measures in Japan, we can accelerate the process of securing clinical hospitals and patients enrollment, allowing us to proceed with CARTISTEM^® treatment as soon as possible.” They further added , “Leveraging the promising results from the domestic Phases 1 and 2, which have been acknowledged by Japan’s PMDA, we are fully committed to achieving positive outcomes in the Japan Phase 3 clinical trial. This marks a crucial step forward in our global expansion strategy for this pivotal year.”