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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo is injected |
|
| Treatment | Experimental | ADRC's are injected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of ADRC's | Drug | ADRC's are injected |
| |
| Injection of Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography | 6 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Duckers, MD, PhD | Erasmus University Medical Centrum, ThoraxCenter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Centrum, Thorax Center | Rotterdam | Netherlands | ||||
| Hospital General Universitario Gregorio Maranon |
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| Other |
Placebo is injected |
|
| Madrid |
| 28007 |
| Spain |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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