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Aastrom Biosciences Says First Patients Enrolled in ixCELL-DCM Phase 2b Clinical Trial of Ixmyelocel-T

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Aastrom Biosciences, Inc. (Nasdaq: ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that the first patients have been enrolled in the ixCELL-DCM clinical trial. This Phase 2b study is currently underway in the United States to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).

The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled phase 2b study with a planned enrollment of 108 patients at approximately 30 sites in the U.S. In the study, ixmyelocel-T will be administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial will be the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure. Patients will be followed for a total of 12 months.

Posted-In: News FDA

 

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