U.S. Firm Wins First Approval of Stem Cell-Based Therapy…In Canada

Friday, June 01, 2012(graphic: Blood & Marrow Transplant Information Network)Virginia-based Osiris Therapeutics Inc. has become the first U.S. company authorized to sell a stem cell-based treatment. The approval, though, did not come from the U.S. government. Rather, Canada's government-run health system okayed the use of Prochymal® for children with acute graft-vs-host disease (GvHD), in which a bone marrow or stem cell transplant attacks the recipient's body.Dr. Andrew Daly, a clinical associate professor from the Department of Medicine and Oncology at the University of Calgary, and leading researcher of Prochymal's phase 3 clinical trial, told Medical News Today: "I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope."Daly compared the approval of the stem cell therapy to the importance of antibiotics becoming available in the late 1920s. 'With stem cells we have now officially taken the first step into this new paradigm of medicine."Prochymal (Remestemcel-L) is derived from stem cells extracted from the bone marrow of adult donors (age 18-30).The therapy will be used to counter GvHD, which kills 80% of children who develop this complication.Osiris hopes to expand the use of Prochymal for other medical conditions, including the repair of heart tissue following heart attacks and to repair lung tissue in patients with pulmonary disease.Prochymal is not the first approved stem cell drug in the world since three different drugs have already been approved for marketing in South Korea.