Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of patients with acute myocardial infarction and a low left ventricular ejection fraction.

Detailed Description
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Aim is to compare the efficiency of sorted subpopulation of CD34+/CXCR4+ cells and unselected bone-marrow-derived progenitor cells in treatment of patients with acute myocardial infarction and low left ventricular ejection fraction. The subpopulation of CD34+/CXCR4+ cells most likely contains the tissue-specific stem cells likely to be involved in myocardial salvage/regeneration after ischemic injury. This approach is novel and original, because so far no study identified the type of cells that actually contribute to stem cell-induced improvement in myocardial function in patients with AMI which were treated with unselected population of cells. The REGENT trial (prospective, randomized, multicentre trial comparing unselected BM mononuclear cells and sorted CD34/CXCR4+ cells in patients with myocardial infarction and low left ventricular ejection fraction) successfully treated with primary percutaneous coronary angioplasty within 12 hours after the onset of chest pain. The cells are delivered by intracoronary infusion. Efficiency is assessed by cardiac magnetic resonance imaging, echocardiography and left ventricular angiography.

Official Title
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Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion. Randomized Multicenter Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Autologous bone marrow-derived stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial infarction treated successfully with primary coronary angioplasty Left ventricular ejection fraction less than 40% Informed consent granted Exclusion Criteria: Presence of significant coronary stenoses in non-infarct related artery requiring revascularization Cardiogenic shock Previous myocardial infarction Age < 18 years and > 75 years Pregnancy Neoplasm Contraindications for MRI

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous bone marrow-derived stem cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction and volumes measured by echocardiography |  | 6 months | 
| Left ventricular ejection fraction and volumes measured by angiography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 6, 12 months | 
| Left ventricular function in dobutamine stress test |  | 6 months | 
| Coronary flow reserve by adenosine MRI test |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cells, acute myocardial infarction, regeneration, left ventricular ejection fraction