Aastrom Biosciences, Inc. Announces Positive 12-Month Safety And Efficacy Data From IMPACT-DCM Phase 2 Clinical Trial For Ixmyelocel-T in Treatment Of Dilated Cardiomyopathy

Aastrom Biosciences, Inc. announced that 12-month follow up data from the IMPACT-DCM clinical trial for ixmyelocel-T showed that treatment was well-tolerated and that efficacy observations were consistent with improved function of impaired myocardium in patients with dilated cardiomyopathy (DCM) including ischemic cardiomyopathy (ICM) and idiopathic dilated cardiomyopathy (IDC). Results were reported today by Amit N. Patel, associate professor of surgery at the University of Utah School of Medicine and national principal investigator for Aastrom's U.S. Phase 2 IMPACT-DCM clinical trial, in a poster presentati. In the study, 40 patients diagnosed with ICM or IDC were randomized 3 to 1 to either a single administration of ixmyelocel-T or standard of care and were followed for 12 months. In the ixmyelocel-T treatment group, bone marrow cells were cultured using Aastrom's technology to expand the number of mesenchymal cells, monocytes and macrophages while retaining many of the mononuclear cells. This combination has been associated with biological activity that promotes tissue remodeling, immunomodulation, and promotion of angiogenesis. Twenty-one of the 25 (84%) ixmyelocel-T patients completed the 12-month visit. Seven of 15 (47%) of the control patients completed the 12-month visit, while an additional 5 of 15 (33%) of the control patients enrolled into the extension phase of the study and received ixmyelocel-T treatment.