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Japan became the new global epicentre for cell therapy after approving the Act on the Safety of Regenerative Medicine (ASRM) which provided a progressive new framework for development and approval of regenerative medicine products.
In September 2015 Japanese regulators approved Terumo’s innovative ex vivo product Heartsheet® for treating severe heart failure caused by chronic ischemic heart disease and Mesoblast Ltd. in partnership with JCR Pharmaceuticals Co. Ltd.’s allogeneic mesenchymal stem cell product TemCell® HS Inj. for use in Acute Graft-versus-Host Disease which is to be used after bone marrow or hematopoietic stem cell transplants.
A handful of companies have ventures underway in Japan, including Athersys, RepliCel, Pluristem, and Mesoblast. In March, Athersys announced a partnership with Japan’s Chugai Pharmaceuticals to develop MultiStem to treat ischemic stroke patients in Japan. RepliCel and its Japanese partner Shishedo already have trials underway for RCH-01, a therapy to reverse pattern baldness in men and women.
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