(HealthDay News) – For patients with chronic ischemic heart failure, transendocardial injection of autologous bone marrow mononuclear cells (BMCs) is not associated with improved prespecified outcomes.
Emerson C. Perin, MD, PhD, from St. Luke’s Episcopal Hospital in Houston, and colleagues conducted a Phase 2 trial of 153 symptomatic patients with coronary artery disease or left ventricular dysfunction and limiting heart failure or angina. Participants had a left ventricular ejection fraction of <45%, a single-photon emission tomography (SPECT) perfusion defect, and coronary artery disease not amenable to revascularization; all participants were receiving maximal medical therapy. Ninety-two patients were randomized in a 2:1 ratio to receive bone marrow aspiration and transendocardial injection of 100 million BMCs or placebo.
At six months, the researchers found that there were no significant changes in left ventricular end-systolic volume (LVESV), maximal oxygen consumption, or reversible defects. No significant differences were seen in any of the secondary outcomes, including percent myocardial defect, defect size (total and fixed), regional wall motion, and clinical improvement.
“Among patients with chronic ischemic heart failure, transendocardial injection of autologous BMCs compared with placebo did not improve LVESV, maximal oxygen consumption, or reversibility on SPECT,” the authors write.
Several of the authors disclosed financial ties to the pharmaceutical and biotechnology industries.