Aastrom Biosciences Inc. (ASTM) said that it will initiate its second clinical trial for the treatment of dilated cardiomyopathy or DCM, a severe disease associated with chronic heart failure, after a positive 30-day review of Aastrom's Investigational New Drug submission by the FDA.
This second trial is a 24 patient U.S. Phase II clinical trial to evaluate the catheter delivery of Cardiac Repair Cells for the treatment of DCM. The study will seek to enroll 12 patients with ischemic DCM and 12 patients with non-ischemic DCM at two clinical sites in the U.S.
The new trial expands the company's cardiovascular program that includes a U.S. Phase II IMPACT-DCM clinical trial evaluating the direct surgical delivery of CRCs.
The FDA previously granted CRCs an Orphan Drug Designation for the treatment of DCM.
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