Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction (REVITALIZE)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Heart Attack, Infarct, Stem Cells, Bone Marrow Derived Mononuclear Cells, CHF, Congestive Heart Failure, Stent, PCI, Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria:
Patients with acute myocardial infarction (ST elevation in at least 2 leads ≥ 0.2 mV in V1,V2 or V3 or ≥ 0.1 mV in other leads), treated by one of the following procedures:
- Acute PCI with stent implantation for acute ST elevation MI for either denovo lesions or in-stent thrombosis
- Treatment with thrombolysis followed by PCI with stent implantation.
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- At the time of inclusion (≥ 1 day post PCI) patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality on echocardiography at the time of acute PCI (ejection fraction ≤ 50% on visual estimation).
- Maximal cardiac troponin elevation ≥ 4 (measured at 37° C)
- Age 18 - 80 Years
- Written informed consent
Exclusion Criteria:
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
- Need to acutely revascularize additional vessels, outside the infarct artery.
- Arteriovenous malformations or aneurysms
- Active infection or fever or diarrhea within last 4 weeks.
- Chronic inflammatory disease
- HIV infection or active hepatitis
- Neoplastic disease without documented remission within the past 5 years.
- Cerebrovascular insult within 3 months
- Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
- Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1.5)
- Anemia (hemoglobin < 8.5 g/dl)
- Platelet count < 100,000/µl
- Hypersplenism
- History of bleeding disorder
- Gastrointestinal bleeding within 3 months
- Major surgical procedure or trauma within 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental retardation
- Previously performed stem / mononuclear cell therapy
- Participation in another clinical trial within the last 30 days
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Experimental
Autologous bone marrow stem cells
Patients within 3 to 14 days from percutaneous coronary intervention (PCI) and stent implantation for Acute Myocardial Infarction (AMI) will receive either 50 cc's or 100 cc's of autologous bone marrow mononuclear cells through an intracoronary tranplantation of stem cells into the infarct-related coronary artery.