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Ixmyelocel-T well-tolerated for cardiomyopathy patients
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Heart Failure Society of America 15th Annual Scientific Meeting
Intramyocardial injection of ixmyelocel-T was safe and well tolerated as a treatment in patients with ischemic cardiomyopathy and idiopathic dilated cardiomyopathy, according to an abstract from the 15th Annual Scientific Meeting of the Heart Failure Society of America.
Researchers randomly assigned 40 patients diagnosed with ischemic cardiomyopathy or idiopathic dilated cardiomyopathy, NYHA HF Class III/IV and a left ventricular ejection fraction mean of 27.4% to a single administration of ixmyelocel-T (Aastrom Biosciences) or a non-treatment control group. Treated patients underwent mini-thoracotomy or thoracoscopy for ixmyelocel-T injection into the left ventricular, according to the abstract. The researchers cultured bone marrow cells for 12 days in a closed system. All patients were followed for 12 months.
Overall, 28 patients completed the study, and researchers found no difference of adverse events in treated and control patients. According to the abstract, ixmyelocel-T had a greater effect in patients with ischemic cardiomyopathy, as well as a better overall outcome vs. the control group. Although there were no cells injected into the septum, researchers found an increase in septal thickening.
“Based on the encouraging safety and early efficacy in patients with ischemic dilated cardiomyopathy using Ixmyelocel-T, further study of minimally invasive cell delivery should be performed in a larger Phase 2 or 3 study,” Amit Patel, MD, from the University of Utah, told Cardiology Today.
Disclosure: Dr. Patel received research report from and was national study PI for Aastrom Biosciences.
For more information:
- Patel A. #186. Presented at: 15th Annual Scientific Meeting of the Heart Failure Society of America; Sept. 18-21, 2011; Boston.
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