Mesenchymal Stem Cells to Treat Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Detailed Description
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Ischemic heart disease is a major public health problem in the industrialized and developing world. Current research is focusing on the development of cell-based therapies using stem cells to treat heart failure. Mesenchymal stem cells (MSCs) can differentiate into endothelial cells and participate in the development of new blood vessels in the heart damaged. Therefore, MSCs has shown promise for heart repair. The investigators study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.

Official Title
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Autologous Grafting of Mesenchymal Stem Cells in Severe Refractory Ischemic Cardiomyopathy

Conditions
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Ischemic Cardiomyopathy

Intervention / Treatment
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* Procedure: MSCs injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic coronary artery disease NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with. Ejection fraction between 35% and 55%. Stable medical therapy for at least one month Patients clinically treated with coronary angioplasty with or without intraluminal stent. Patients with surgical revascularization and without the possibility of new invasive intervention. Exclusion Criteria: Human immunodeficiency virus (HIV1-2), HTLV-1 and 2. An active uncontrolled infection. Pregnancy. Mental disability. Terminal illnesses. Valvular heart disease, congenital heart disease or other causes of cardiomyopathy than ischemic. Life perspective by other diseases under 1 year. History of severe arrhythmias Renal dysfunction or against medication Inability to perform cardiac catheterization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSCs injection<br>Injection of autologous bone marrow-derived mesenchymal cells | Procedure: MSCs injection<br>* MSCs cells will be injected in two aliquots of 10 ml by catheterism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiogram. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Measures by specific questionnaire of quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ) | 3 months, 6 months, 12 months | 
| Changes in exercise capacity |  | 1 year | 
| Changes in plasma inflammatory markers |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases, Myocardial Ischemia, Coronary Artery Disease, Heart Diseases, Coronary Disease, Ventricular Dysfunction, Arteriosclerosis