Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.

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. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.

Inclusion Criteria:

• Patients with diagnosis of myocardial infarction, absence of viability.
• Ejection fraction under 40% or 45% in symptomatic patients
• Aged from 30-80 years old.
• Negative pregnancy test (women of childbearing age)
• Informed consent granted

Exclusion Criteria:

• Prior history of tachycardia or ventricular fibrillation (except in the acute phase of MI).
• Myocardial infarction with more than 10 years of evolution.
• Patients positive for HIV, HBV or HCB.
• Patients with organ dysfunction: liver and kidney function
• History of cancer or prior treatment with chemotherapy.
• The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
• Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
• Pregnant or beast feeding women.