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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A | Active Comparator | Dose A |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose A | Biological | ADRC Dose A |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Infarct Size | Reduction in infarct size at 6 months as measured by cardiac MRI | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE Rates | Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint | Through 36 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Kesten, MD | Cytori Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Centrum | Rotterdam | Netherlands | ||||
| Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn |
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| Placebo | Biological | Placebo Comparator |
|
| Krakow |
| 31202 |
| Poland |
| Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki | Krakow | 31501 | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej | Warsaw | 02097 | Poland |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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