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MediPost’s Cartistem Succeeds in Japan Phase 3 Trial

Dong-A Ilbo | Updated 2026.05.13
 
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 for “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 trial in Japan. The trial was conducted on 130 patients with Grade 2–3 knee cartilage damage at 13 local medical institutions, and safety and efficacy were observed over 52 weeks by comparing with a control group treated with sodium hyaluronate (HA) injections.

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

Cartistem is the world’s first allogeneic umbilical cord blood-derived mesenchymal stem cell therapy, which received product approval from 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 undergone Cartistem procedures to date. Division head Lee Seung-jin 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 reestablish itself as a leading stem cell enterprise that brings new hope to osteoarthritis patients worldwide.”

Kim Jae-hyung

AI-translated with ChatGPT. Provided as is; original Korean text prevails.
ⓒ dongA.com. All rights reserved. Reproduction, redistribution, or use for AI training prohibited.
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