· Clinical Trials Notification(CTN) for phase-3 trial to be filed in Japan this year after delay related to COVID-19
· Phase 1 trial of injectable knee osteoarthritis cell therapy product (code name: SMUP-IA-01) is due to be completed by end of this year in Korea
MEDIPOST, a leading stem cell biotechnology company, today announced the initiation of a phase 2 clinical trial of CARTISTEM®, an allogeneic stem cell therapy product for knee osteoarthritis, in Japan.
The study was originally scheduled to commence in the first quarter of this year following the clearance of CTN approval in December 2019, however it was delayed due to the impact of the COVID-19 pandemic. In Japan, a phase 1 clinical trial was omitted as the previous clinical trial data from Korea was recognized by the Japan’s regulatory authority to directly enter into the phase 2 clinical trial which is designed to enroll 50 patients with Kellgren & Lawrence(K&L) grade 2-4 who will also undergo high tibial osteotomy(HTO) procedure.
“Japan is becoming a ‘ultra-aging society’ with more than 10 times the number of knee osteoarthritis patients than Korea. Japan has a well-established healthcare system for patients with degenerative diseases with high interest in advanced regenerative medicine products including cell therapy products, making it an ideal market for CARTISTEM® outside Korea,” said a MEDIPOST official.
“We are also working on regulatory documentation to file for approval of a phase 3 clinical trial in Japan within this year, the progress of which was also delayed due to the pandemic. It will make 2020 to be the first year of clinical development for entering into the Japanese market, one of the world’s largest knee osteoarthritis markets.”
Meanwhile, the company’s ongoing phase 1 clinical trial of injectable knee osteoarthritis cell therapy product (code name: SMUP-IA-01) for K&L grade 2 or 3 patients, is due to be completed in Korea by the end of this year, and the next-stage clinical trial will follow immediately after confirming positive outcome from the phase 1 clinical trial which is expected during the first half of next year.
* High tibial osteotomy(HTO) is an orthopedic surgical procedure to correct a varus deformation in patients with compartmental osteoarthritis, thereby reducing knee pain and improving knee function.