Rehabilitative treatment using stem cells cultured in Korea will commence in Japan next month!

• Biostar Stem Cell Research Institute completed the field inspection and supplementary document submission required by the Ministry of Health, Labour and Welfare (MHLW) of Japan for approval
• Stem cells cultured in Korea will be supplied to Japanese medical facilities following MHLW approval

Biostar Stem Cell Research Institute, jointly operated by Nature Cell and R Bio, announced on January 7 that it has completed the necessary procedures including the field inspection and supplementary document submission for the approval of manufacturing processed cellular products at the Cell Processing Center in Korea, as required by the Ministry of Health, Labour and Welfare (MHLW) of Japan.

Officials from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, which is equivalent to Korea’s Ministry of Food and Drug Safety, visited the Cell Processing Center on December 2 last year for a field inspection. The relevant application documents were edited as necessary, and supplementary documents regarding the relocation of unused equipment were submitted as of January 5.

R-Japan, an affiliate of Biostar, acquired the approval for manufacturing processed cellular products from MHLW of Japan last June, and Biostar Stem Cell Research Institute applied for approval of a domestic stem cell manufacturing facility in August. According to the Act on Ensuring the Safety of Regenerative Medicine in Japan, enterprises and medical institutions are prohibited from storing and culturing cells in Japan, unless they are granted approval from MHLW, and overseas stem cell facilities are able to culture and supply stem cells to the medical institutions in Japan if they are granted MHLW approval.

Ra Jeong-chan, the President of Biostar Stem Cell Research Institute, said, “The stem cell manufacturing facility in Korea will be granted manufacturing approval from the Japanese government, just like the local research institute in Japan. It brings us great pleasure, knowing that we will be opening a new era of adipose-derived stem cell treatment at Japanese medical facilities and provide treatment to patients coming from around the world.”

R-Japan has been supply stem cells for treatment of Buerger’s disease, critical limb ischemia (CLI), degenerative arthritis, skin regeneration and autoimmune diseases since November last year.

The Japanese government has designated regenerative medicine as a national growth engine, and enacted the Regenerative Medicine Law. The system was then changed from allowing doctors at hospitals and medical clinics to engage in cell cultivation and processing practices to requiring MHLW’s approval of the processed cellular product manufacturing facilities for safety assurance purposes. Also, the law necessitates a regenerative medicine treatment plan, which is to be approved by an expert committee before it can be applied in a clinical setting.