Two-Year Heart Failure Study with Allogeneic Myoblast Transplantation

Objectives: Allogeneic myoblast transplantation (AMT), cyclosporine immunosuppression and coronary artery bypass grafting (CABG) were used to treat end-stage heart failure (HF) subjects without hope of obtaining a heart transplant. Background: Severe myocardial infarction conveys serious complications such as ventricular aneurysm, wall thinning and rupture with fatal consequences. Methods: After meeting Inclusion/Exclusion criteria and signing Patient Informed Consents, 10 HF subjects having mean thinnest wall thickness of 2.21 ± 0.55 mm and ventricular aneurysms were admitted under intensive care. Each subject took daily cyclosporine for three weeks. On the third day of cyclosporine administration, approximately 1 billion myoblasts were implanted through 20 injections into the infarcted myocardium following CABG. Results: Safety No subject suffered death, viral infection, malignant arrhythmia, reduction in cardiac output, immune rejection, or aneurysm growth. No significant difference was found before versus after treatment in the mean levels of blood routine, liver and kidney enzymes, electrolytes and fibrinogen. Efficacy Emission computed tomography (ECT) and magnetic resonance (MR) demonstrated significant increases in viability and perfusion. Mean left ventricular ejection fraction (LVEF) significantly increased (P < 0.05) by 20.1% and 19.3% at 6 months and at 2 years postoperatively. New York Heart Association (NYHA) class improved by 2 grades, including 6-minute walk test (6 MWT) distance increase, and reductions in the number of episodes of angina pectoris, chest tightness, shortness of breath after exercise, and nighttime sit-up breathing. Conclusions: For the first time, AMT in adjunct use with CABG and cyclosporine demonstrated that cell survived and engrafted in patients with ischemic cardiomyopathy; in this small study the cell transplant was safe. The improvement in heart function and quality of life could be secondary to combined effect of bypass and cell transplant. A larger randomized clinical trial is required to confirm the efficacy.