The purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.
Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. Depending on the area affected by the scar, infarction can lead to a progressive and irreversible decline in cardiac function, giving way to heart failure (HF) syndrome. The molecular basis of congestive heart failure is the absence of cardiac stem cells capable of regenerating cardiac muscle. In the skeletal muscle, there are cells located beneath the basal membrane with are capable of regenerating muscle fibres; they are known as myoblasts. There are several studies with autologous myoblasts, either by direct administration during surgery or percutaneously, which could distinguish between the effect of revascularisation surgery and that of the myoblast injection. The objective of this study is compare improvement in global and regional cardiac function in patients with old MI obtained by aortocoronary bypass surgery with intracardiac administration of autologous skeletal myoblasts versus standard aortocoronary bypass surgery treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Intra-lesion injection
Revascularisation surgery
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
The primary efficacy endpoints will be evaluate the ejection fraction and wall motion score index measured by M-mode and echocardiography 12 months after surgery.
Time frame: 12 months after surgery
Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.
Time frame: 12 month after surgery
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Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital La Fe
Valencia, Valencia, Spain