[Asia Economy Reporter Lee Chun-hee] Medipost's knee osteoarthritis treatment 'Cartistem' has officially begun clinical trials for its entry into the Japanese market.
Medipost announced on the 16th, "We have completed the first patient dosing for the Phase 3 clinical trial of Cartistem in Japan, which had been delayed due to COVID-19." Cartistem received approval for Phase 3 clinical trials from Japan's Ministry of Health, Labour and Welfare in February 2021, but the trials had been postponed due to the pandemic. Recognized for its domestic clinical results, it is the first advanced biopharmaceutical in Korea to skip Phases 1 and 2 and proceed directly to Phase 3 clinical trials.
This Phase 3 trial will involve a total of 130 patients with mild to moderate knee osteoarthritis (K&L grades 2 to 3). Patients will be divided into two groups: the treatment group will receive Cartistem, and the control group will receive hyaluronic acid injections. After 52 weeks of follow-up, improvements in joint function, pain relief, and regeneration of damaged knee cartilage will be compared and analyzed.
Since the proficiency and expertise of the surgeons performing the operation are crucial for Cartistem, Medipost plans to actively transfer Korea's accumulated surgical know-how to Japanese medical staff to achieve the targeted clinical outcomes. To this end, medical personnel from Japanese clinical trial hospitals will be invited to Korea to observe Cartistem surgeries firsthand and receive training on surgical techniques. Additionally, Cartistem symposiums will be continuously held in Japan to enhance the skills of local medical professionals and to create pre-marketing effects in preparation for future commercialization.
Cartistem is the world's first allogeneic umbilical cord blood-derived stem cell therapy. Unlike existing osteoarthritis treatments that focus on pain relief and temporary functional improvement, Cartistem has proven efficacy through fundamental therapeutic effects that suppress inflammation and regenerate damaged cartilage tissue into natural cartilage. Since its domestic approval in 2012, there have been over 25,000 surgical cases and cumulative sales have surpassed 100 billion KRW.
A Medipost official stated, "With the easing of COVID-19 prevention measures in Japan, we can accelerate securing clinical trial hospitals and patient enrollment, aiming to complete patient registration and dosing as soon as possible." They added, "Since the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has recognized the excellent results of our domestic Phases 1 and 2 clinical trials, we will do our best to achieve good results in the Japanese Phase 3 trial and make this year a foundation for our global expansion."
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