The peer-reviewed journal Circulation Research publishes Aastrom Biosciences' (ASTM +9.1%) Phase 2a clinical trial results for its heart failure therapy candidate ixmyelocel-T as a treatment for advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The study entitled "Safety and Efficacy of Ixmyelocel-T: An Expanded, Autologous Multi-Cellular Therapy, in Dilated Cardiomyopathy" showed that treatment with ixmyelocel-T reduced the incidence of major adverse cardiovascular events (MACE) in patients with ischemic DCM.
In two open-label studies, a total of 61 patients were randomized. Fifty-nine were treated with ixmyelocel-T or standard-of-care (SOC). The ixmyelocel-T group experienced fewer MACE events than the SOC group, although the results do not appear to be statistically significant.
A poster on an ixmyelocel-T study involving 39 patients disclosed that certain characteristics in the study design made it difficult (translation: impossible) to draw conclusions about efficacy. The only conclusion was the noting of some consistent trends. The published study only involves 20 additional subjects so the "conclusions" are most assuredly the same.