Korea’s stem cell treatment technology, receives official approval from the Japanese government

• Nishihara Clinic, obtains approval from MHLW of Japan for treatment of critical limb ischemia including Buerger’s disease
• Supplying stem cells to R-Japan, an affiliate of Nature Cell, and Nishihara Clinic for treatment of Buerger’s disease
• An opportunity for Buerger’s disease and diabetic foot ulcer patients around the world to regain their health in Japan

On November 11, R-Japan Co., Ltd., an affiliate of Nature Cell in Japan, announced that its medical institution partner, Nishihara Clinic, acquired approval for stem cell treatment of critical limb ischemia (CLI) and Buerger’s disease from the Japanese Ministry of Health, Labour and Welfare (MHLW), based on a project initiated by the Biostar Stem Cell Research Institute.

This has an important significance in that the medical technology developed by Korea’s Biostar for treatment of severe lower limb ischemic diseases such as Buerger’s disease and diabetic foot ulcers has been approved for the first time in the world by the Japanese government.

R-Japan submitted an application form for treatment approval, together with Nishihara Clinic, and it was reviewed by the Committee on Specifically Recognized Regenerative Medicine on September 15, and approved by the Japanese government on October 16. An application for final approval was submitted to MHLW on October 21, and final approval was granted on November 10. With the approval of MHLW, the research and development (R&D) efforts of Biostar finally paid off in one of the most advanced nations in the world.

In Japan, enterprises granted the stem cell manufacture approval can supply stem cells to the approved medical institutions, pursuant to the Act on Ensuring the Safety of Regenerative Medicine, starting on November 25. R-Japan, a partner of Biostar that acquired the approval for manufacturing processed cellular products on June 29, plans to make an effort to emerge as a leading supplier of stem cells for therapeutic purposes in Japan after initially supplying to Nishihara Clinic.

At present, there is an estimated 100,000 patients suffering from ischemic diseases of the lower extremities including Buerger’s disease in Japan. It has also been reported that approximately 1 million patients receive lower limb amputation surgery as a result of related diseases on a yearly basis worldwide. R-Japan projects that it will be possible to supply stem cells for at least 8,000 patients from around the world in 2016, 20,000 patients in 2017 and 50,000 patients in 2018.

Ra Jeong-chan, the President of Biostar and founder of R-Japan, said, “We will continually dedicate ourselves to research and pioneer the ‘Stem Cell Silk Road’ to help intractable disease patients from around the world regain their health, with our adult stem cell technology.”