Posted on Dec 05, 2013, 6 a.m.
Transendocardial stem cell injection (TESI) with stem cells and bone marrow cells is confirmed as an effective therapy in patients with ischemic cardiomyopathy.
Ischemic cardiomyopathy is a heart condition in which the left ventricle – the main heart muscle – pumps blood poorly. Alan W. Heldman, from the University of Miami Miller School of Medicine (Florida, USA), and colleagues conducted a study involving 65 patients with ischemic cardiomyopathy and compared injection of mesenchymal stem cells (n=19) with placebo (n = 11) and bone marrow mononuclear cells (n = 19) with placebo (n = 10), with 1 year of follow-up. The primary measured outcome was treatment-emergent 30-day serious adverse event rate defined as a composite of death, heart attack, stroke, hospitalization for worsening heart failure, perforation (rupture), tamponade (compression of the heart due to collection of blood or fluid), or sustained ventricular arrhythmias. No patient had treatment emergent-serious adverse event at day 30. Exploratory analyses of 1-year incidence of serious adverse events was 31.6% for mesenchymal stem cells, 31.6% for bone marrow cells, and 38.1\% for placebo. Over 1 year, the Minnesota Living with Heart Failure score (a measure of quality of life) improved with mesenchymal stem cells and with bone marrow cells but not with placebo. The 6-minute walk distance increased with mesenchymal stem cells only. Writing that: “Transendocardial stem cell injection with [mesenchymal stem cells] or [bone marrow mononuclear cells] appeared to be safe for patients with chronic ischemic cardiomyopathy and [left ventricle] dysfunction,” the study authors are hopeful that: “ these results provide the basis for larger studies to provide definitive evidence about safety and to assess efficacy of this new therapeutic approach.”
Heldman AW, Difede DL, Fishman JE, Zambrano JP, Trachtenberg BH, Hare JM, et al. “Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells for Ischemic Cardiomyopathy: The TAC-HFT Randomized Trial.” JAMA. 2013 Nov 18.