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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.
Comments (2)
  • bill prather
    , contributor
    Comments (3) | 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, 03:22 AM Reply Like
  • MD Research
    , contributor
    Comments (205) | Send Message
     
    When trial data are not statistically significant at Phase 2a, the only person profiting from this is the pumper!
    29 Aug, 05:43 PM Reply Like
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