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December 12, 2012

Mixed Results for Bone Marrow–Derived Cell Therapy for Ischemic Heart Disease

Author Affiliations

Author Affiliations: Cedars-Sinai Heart Institute, Los Angeles, California.

JAMA. 2012;308(22):2405-2406. doi:10.1001/jama.2012.64751

Two early-phase studies reported in JAMA1,2 address the same general question: what is the effect of bone marrow–derived cell therapy on safety and surrogate end points in patients after myocardial infarction (MI)? Other than this thematic similarity, the Timing In Myocardial infarction Evaluation (TIME) trial and the POSEIDON trial have little in common. The TIME trial1 examined 120 patients with a recent (3-7 days) acute MI (AMI) and autologous mononuclear cells (MNCs) delivered via the intracoronary route with the intervention on day 3 (n = 67) or on day 7 (n = 53). This was a placebo-controlled, multicenter trial with a fixed dose of MNCs. The major motivation was to test the concept that timing of MNC therapy within the first week after MI influences outcome. The POSEIDON trial2 involved patients with ischemic cardiomyopathy after distant MIs (years earlier) and used autologous or allogeneic mesenchymal cells (MSCs) administered transendocardially via injection catheters. Two centers recruited 30 patients and randomly assigned them into 1 of 6 permutations of cell origin (self or donor) and dosage (n = 5 patients each), with no controls. The goal of the trial was to compare the safety and efficacy of self-derived MSCs with donor MSCs in chronic ischemic cardiomyopathy.

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