Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)

Study Overview
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Brief Summary
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Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).

Detailed Description
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This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.

Official Title
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A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Biological: Dose A
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: ST-segment Elevation Myocardial Infarction (STEMI) Criteria: Ischemic symptoms AND ECG: Development of pathologic Q waves on the ECG; or ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or New left bundle branch block; AND Creatine Phosphokinase Isoenzyme (MB Form) > 100 IU/L, or troponin >5x the upper limit of normal between admission and randomization Successful revascularization of the culprit lesion in a major epicardial vessel Key Exclusion Criteria: More than 24 hours between PCI and start of liposuction Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure Pacemaker, ICD, or any other contra-indication for MRI Patients with increased bleeding risk Cardiogenic shock present post-index PCI

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 |
| --- | --- |
| Active Comparator: Dose A<br>Dose A | Biological: Dose A<br>* ADRC Dose A<br>* Other names: Adipose-Derived Regenerative Cells;|
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo<br>* Placebo Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Infarct Size | Reduction in infarct size at 6 months as measured by cardiac MRI | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE Rates | Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint | Through 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Attack, Regenerative Cells, Stem Cells