Medipost(42,250 +1.08%)Announced on the 2nd that it has applied to the Ministry of Health, Labor and Welfare in Japan for approval (CTN) for the clinical trial plan of Katistem (EVA-001), a stem cell treatment for knee osteoarthritis.
Cartistem is the world’s first treatment for knee cartilage defects developed with mesenchymal stem cells derived from allogeneic cord blood. In 2012, it was approved by the Korean Ministry of Food and Drug Safety.
The Japanese phase 3 is conducted in 130 patients with mild and moderate knee osteoarthritis (K&L grades 2-3). Efficacy and safety were evaluated between the group to which Cartistem was administered once and the control group of the hyaluronic acid preparation.
The clinical trial is handled by Evastem, a Japanese joint venture. This clinical trial was recognized for the clinical and long-term follow-up results of Katistem in Korea. Therefore, it is explained that phase 1 and phase 2 of clinical trials are omitted, and phase 3 is performed in a single phase with the aim of formal product approval.
Separately, Medipost was approved for phase 2 clinical trials in Japan for patients with proximal tibia osteotomy (HTO) among K&L grade 2-4 patients in 2019. Currently, clinical trials are in progress.
A Medipost official said, “By acknowledging the outstanding cartilage regeneration effect of Cartistem through domestic clinical trials and patient prescriptions for several years, we have applied for phase 3 clinical trials in Japan immediately.” “We plan to accelerate our advancement to Japan by successfully conducting two clinical trials in progress.”
Reporter Kim Ye-na [email protected]
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