Aastrom heart failure therapy trial results published

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.

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Comments (2)
  • bill prather
    , contributor
    Comments (5) | Send Message
    Is the poster available for review? The paper from Circulation Research cost $40 but the abstract suggest there may have been a trend toward efficacy. I can understand there would be no problems with safety as these cells are autologous
    23 Aug 2014, 03:22 AM Reply Like
  • MD Research
    , contributor
    Comments (208) | Send Message
    When trial data are not statistically significant at Phase 2a, the only person profiting from this is the pumper!
    29 Aug 2014, 05:43 PM Reply Like
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