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.
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