Surgical treatment for congestive heart failure with autologous adult stem cell transplantation: a prospective randomized study.

BACKGROUND Autologous adult stem cell transplantation has been touted as the latest tool in regenerative medical therapy. Its potential for use in cardiovascular disease has only recently been recognized. A randomized study was conducted with a novel epicardial technique to deploy stem cells as an adjuvant to conventional revascularization therapy in patients with congestive heart failure. METHODS After institutional review board and government approval, adult autologous stem cell transplantation (CD34+) was performed in patients with ischemic cardiomyopathy and an ejection fraction of less than 35% who were scheduled for primary off-pump coronary artery bypass grafting. Preoperatively, the patients underwent echocardiography, stress thallium imaging single photon emission computed tomography, and cardiac catheterization to identify ischemic regions of the heart and to guide in the selection of stem cell injection sites. The patients were prospectively randomized before the operative therapy was performed. Patient follow-up was 1, 3, and 6 months with echocardiography, single photon emission computed tomography, and angiography. RESULTS There were 20 patients enrolled in the study. Ten patients had successful subepicardial transplantation of autologous stem cells into ischemic myocardium. The other 10 patients, the control group, only had off-pump coronary artery bypass grafting. There were 8 male and 2 female subjects in each group. The median number of grafts performed was 1 in both groups. On angiographic follow-up, all grafts were patent at 6 months. The ejection fractions of the off-pump coronary artery bypass grafting group versus the off-pump coronary artery bypass grafting plus stem cell transplantation group were as follows: preoperative, 30.7% +/- 2.5% versus 29.4% +/- 3.6%; 1 month, 36.4% +/- 2.6% versus 42.1% +/- 3.5%; 3 months, 36.5% +/- 3.0% versus 45.5% +/- 2.2%; and 6 months, 37.2% +/- 3.4% versus 46.1% +/- 1.9% (P < .001). There were no perioperative arrhythmias or neurologic or ischemic myocardial events in either group. CONCLUSIONS Autologous stem cell transplantation led to significant improvement in cardiac function in patients undergoing off-pump coronary artery bypass grafting for ischemic cardiomyopathy. Further investigation is required to quantify the optimal timing and specific cellular effects of the therapy.