Two recent randomized trials published in the Journal of the American Medical Association have reported diverging results regarding the safety and efficacy of bone marrow-derived cell therapy for ischemic heart disease. Led by researchers from the Interdisciplinary Stem Cell Institute, the POSEIDON trial compared the use of autologous to allogeneic mesenchymal stem cell injections among 30 patients with left ventricular dysfunction due to distant ischemic cardiomyopathy. The study found that both the autologous and allogeneic therapies were associated with low rates of treatment-emergent serious adverse events. Researchers suggested that either therapy could improve patient functional capacity, quality of life, and ventricular remodeling, but the POSEIDON trial was limited by its small sample size and the lack of a control group. A second study led by the Cardiovascular Cell Therapy Research Network assessed the effect of timing of intracoronary autologous bone marrow mononuclear cell (BMC) delivery on global and regional left ventricular function among patients who had recently experienced ST-segment elevation myocardial infarction. The trial found that there was no significant benefit of BMC delivery at either 3 or 7 days after treatment, as compared to placebo. An upcoming phase 3 trial in Europe evaluating the use of mononuclear cells after acute myocardial infarction is expected to provide further clarification of the role of cellular therapy for these patients.
References
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3. Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA 2012;308: 2369-79.
