Japan Eases Stem Cell Restrictions

Staff of the Australian biotech firm Mesoblast, claimed by its founder to be the biggest player in this particular biotechnology sector, is excited about this week’s legislative change in Japan. The change will allow fast-track approvals of stem cell products. Japan’s Diet passed bills to both ensure the safety of regenerative medicine products and enable swift medical treatment using stem cells.

Mesoblast’s Chief Executive and Founder Silviu Itescu told Inside Business that the bills enable Japan’s government to approve new products conditionally, providing their safety is confirmed in clinical trials, even if their efficacy has not yet been verified. “The Japanese legislature has, just for stem cell products, defined them in a unique category as regenerative medicine, ” he said. The change means such products might be approved for the Japanese market without having to complete “phase-three” trials.

Mesoblast has begun a partnership with Japanese pharmaceutical company JR Pharmaceuticals for one of its products for graft-versus-host disease which is a major complication after a bone marrow transplant. “We expect that if the Japanese regulators look at that product in a favourable way, that will be the first product launch in Japan in the stem cell space under our arrangement with JCR, ” Itescu said.

Mesoblast has focused its work using mesenchymal precursor cells (MPC) on inflammatory and immune system diseases, cardiovascular diseases and orthopaedic diseases of the spine where MPCs can be locally administered to potentially repair intervertebral discs or generate new bone.