Sewon Cellontech said Monday that Olympus RMS has submitted phase 3 clinical trial plans for Chondron, a cartilage cell therapy, to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Olympus RMS is a joint venture between Sewon Cellontech and Olympus.
Chondron is an autologous cell therapy that involves regeneration of cartilage caused by aging or repetitive trauma. The treatment was the first cell therapy approved in Korea and has treated more than 6,000 patients in the U.K., Netherland, Poland, India, China, Singapore, and Malaysia. Such extensive use was vital in the Ministry of Health and Welfare recognizing the treatment as a new medical technology in 2012.
The treatment also has 14 related clinical trials listed in international journals and 28 domestic and overseas patents.
After the Japanese agency approves phase 3 clinical trials, the company expects to start clinical trials in 10 leading university and general hospitals by the second quarter of next year, using Tokyo Cell Processing Center (CPC) as its base.
“Our company was able to understand the Japanese market well regarding the technical status and industrial value of Chondron,” said Seo Dong-sam 서동삼, managing director of the company 세원셀론텍. “We expect the treatment to take its place in the Japanese market after the phase 3 of clinical trials, thanks to the Tokyo government's policy to foster a strong healthcare industry.”
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