The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Who can participate
Age range21 Years – 85 Years
SexALL
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Inclusion Criteria:
* Male or female between 21 and 85 years old, inclusive
* First heart attack within 7 days prior to randomization and drug infusion
* Baseline left ventricular ejection fraction (LVEF) 20-45%
* Hemodynamically stable within 24 hours prior to randomization
* Adequate pulmonary function
Exclusion Criteria:
* Previous medical history of heart attack, heart failure, significant valvular heart disease, aortic dissection
* Pacemaker or other device
* Pregnant, breast-feeding, or intends to become pregnant during the study
* Allergy to cow or pig derived products
* Evidence of active malignancy or prior history of active malignancy
* Major surgical procedure or major trauma within the past 14 days
* Autoimmune disease (e.g., Lupus, Multiple Sclerosis)
* Any medical condition, which in the opinion of the Investigator, renders participation unsuitable
* Undergone pharmacologic cardioversion or external defibrillation within 24 hours of randomization.
* Experienced cardiac arrest more than 36 hours after presentation to site or within 24 hours of randomization.
What they're measuring
1
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3