Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.

Detailed Description
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Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.

Official Title
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A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial

Conditions
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Myocardial Infarction, Coronary Arteriosclerosis, Cardiovascular Disease, Coronary Disease

Intervention / Treatment
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* Drug: Injection of ADRC's
* Other: Injection of Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Acute myocardial infarction (AMI) Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin Successful revascularization of the culprit lesion in the major epicardial vessel Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization. Ability to undergo liposuction Key Exclusion Criteria: Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF) More than 24 hours after acute PCI Significant valvular disease More than twelve hours between the onset of first symptoms of AMI and revascularization Hemodynamic instability within 24 hours prior to randomization Neoplasia Acute or chronic bacterial or viral infectious disease Pacemaker, ICD or any other contra-indication for MRI LVEF <30% or >50% by Left Ventricular Angiography Moderate or severe COPD

Ages Eligible for Study
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Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo is injected | Other: Injection of Placebo<br>* Placebo is injected<br>|
| Experimental: Treatment<br>ADRC's are injected | Drug: Injection of ADRC's<br>* ADRC's are injected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADRC, Stem Cells, Myocardial Infarction, STEMI, Heart Disease, Coronary Artery Disease, Coronary Disease, ST-Elevation, AMI, Interventional Cardiology, Heart Attack