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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Old Myocardial Infarction

Intervention / Treatment
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* Procedure: Percutaneous autologous myoblast implantation
* Procedure: Cardiac revascularization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skeletal myoblasts<br>Percutaneous autologous myoblast implantation | Procedure: Percutaneous autologous myoblast implantation<br>* Endocavity implantation of autologous myoblasts<br>* Other names: Cellular therapy;|
| Placebo Comparator: No cells<br>Percutaneous culture medium without cells implantation | Procedure: Cardiac revascularization<br>* Cardiac revascularization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction and wall motion score index measured with M-mode and echocardiography |  | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population |  | 12 month after surgery | 
| Viability measured with echocardigraphy and magnetic resonance in the ITT population |  | 12 month after surgery | 
| Incidence of cardiac arrythmias in the ITT population |  | 12 month after surgery | 
| Ejection fraction measured with echocardiography in the ITT population |  | 12 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous implantation of autologous myoblasts