The stem cell therapy for osteoarthritis “Cartistem,” which has recorded cumulative domestic sales of KRW 140.3 billion and has been administered to more than 30,000 patients, has taken its first step toward overseas expansion 14 years after commercialization. Stem cell bio company Medipost announced on the 13th that it has successfully completed Phase 3 clinical trials of Cartistem in Japan.

Medipost held a press conference at the Four Seasons Hotel in Jongno-gu, Seoul, on the 13th and disclosed the results of the Phase 3 clinical trials in Japan. The trials were conducted at 13 local medical institutions with 130 patients suffering from Grade 2–3 knee cartilage damage, and safety and efficacy were observed over 52 weeks by comparing Cartistem with a control group treated with hyaluronate sodium (HA) injections.

During the clinical process, Cartistem met all key efficacy endpoints. One year after the procedure, it demonstrated superiority over the control group in pain and function improvement (WOMAC) and in cartilage regeneration assessment (ICRS).

Cartistem is the world’s first allogeneic umbilical cord blood-derived mesenchymal stem cell therapy, approved as a pharmaceutical product by the Ministry of Food and Drug Safety in 2012. It regenerates cartilage using stem cells extracted from umbilical cord blood, and more than 30,000 patients have received Cartistem procedures to date. Lee Seung-jin, Head of the Global Business Division, said, “The cartilage regeneration effect proven in Korea has been reconfirmed in this Phase 3 trial,” adding that it is “a solid foundation for global expansion.”

Medipost plans to apply for product approval in Japan in the second half of this year (July–December), with the goal of obtaining approval by the end of 2027. CEO Oh Won-il said, “The company will be reborn as a leading stem cell enterprise that offers new hope to osteoarthritis patients worldwide.”

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