Abstract
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 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.
Highlights
Heart muscle degeneration is a leading cause of debilitation and death in humans
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
They were male volunteers between the ages of 16 and 36. They were certified by a physician as being in good health, having normal levels of aspartate aminotransferase (AST), alanine transaminase (ALT), lactate dehydrogenase (LD) and tested negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis (RPR), and cytomegalovirus (CMV)
Summary
Heart muscle degeneration is a leading cause of debilitation and death in humans. Its primary cause is partial or complete obliteration of the coronary artery, often precipitating acute myocardial infarction (AMI). Long-term ischemia leads to ventricular cell death and myocardial necrosis. Transmyocardial revascularization (TMR), and CABG can increase local blood supply and reduce short-term mortality and morbidity, most patients continue suffering decreased ventricular function and chronic heart failure. Severe myocardial infarction conveys serious complications such as ventricular aneurysm, wall thinning and rupture with fatal consequences. Traditional aneurysm resection improves heart contractility by restoring the original oval structure of the left ventricle. This procedure is reserved only for patients with at least medium-sized ventricles because of volume consideration. Prognosis for these severe heart failure patients is three to six months of life despite CABG. It is urgent to explore new therapeutic measures to increase the quality of life and lifespan of these patients
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