Cesca Therapeutics Inc. , an autologous cell-based regenerative medicine company, today announced that it has received a letter from the U.S. Food and Drug Administration responding to the Company's investigational device exemption application for its pivotal CLIRST III clinical trial. The IDE application, filed on November 20, 2014, sought approval to begin a pivotal, randomized, placebo-controlled study of 224 late stage CLI patients at up to 60 clinical sites in the United States and India.
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http://ift.tt/1zZkEE9
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