May 17, 2010 - Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, announced that the first patient has been treated in the company's U.S. Phase 2 catheter-based clinical trial to treat dilated cardiomyopathy (DCM). Treatment was performed by interventional cardiologist Timothy D. Henry, M.D., FACC, at the Minneapolis Heart Institute® at Abbott Northwestern Hospital in Minneapolis, MN.
This prospective, randomized, controlled, multi-center clinical trial is designed to determine the safety and tolerability of Aastrom's tissue repair cells (TRCs), administered via catheter, in the treatment of patients with heart failure due to DCM. The trial seeks to enroll 12 ischemic DCM and 12 non-ischemic DCM patients. Within each group patients are randomized to receive either TRC treatment along with standard-of-care, or control treatment (standard-of-care only) in a 2:1 ratio. While the primary objective of the trial is to assess safety in patients with DCM, efficacy measures including cardiac dimensions, heart failure stage and other measures of cardiac function will be monitored... Aastrom Biosciences' Press Release -
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