Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction (ReNeW)

Inclusion Criteria:

• Be at least 18 years of age and no more than 80 years of age.
• Acute ST-segment elevation MI
• Symptoms suggestive of acute MI
• ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
• Time from symptom onset to enrollment < 120 hours
• Left ventricular dysfunction by contrast ventriculography or echocardiography
• EF above 25 % and lower than 40%
• Focal wall motion akinesis or dyskinesis
• Clearly identifiable infarct artery
• Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement

Exclusion Criteria:

• Planned treatment with bypass surgery or prior CABG
• Multi-vessel PCI
• Prior myocardial infarction by history or presence of pathologic Q-waves
• Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
• Successful reperfusion < 3 hrs from symptom onset
• Prior MI or significant chronic heart failure
• Pacemaker/defibrillator
• Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
• Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance<25 and/or serum Cr >2.5 mg/dl)
• Baseline hematocrit < 30
• Pregnancy, or lactation/parturition within the past 30 days
• Active or planned treatment with chemotherapy
• Anticipated difficulty with 90-day follow-up
• Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
• Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
• Previous enrollment in this trial
• Participation in an investigational drug or device study within the past 30 days