Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute myocardial infarction, AMI, Myocardial infarction, Heart attack, Mesenchymal stem cells, MSC, Adult human stem cells, Osiris
Eligibility Criteria
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.
Sites / Locations
- Mercy Gilbert Medical Center / Catholic Health Care West
- University of Arizona
- UC Davis Medical Center
- University of California - San Diego (UCSD)
- Mount Sinai Medical Center
- University of Miami
- Rush University Medical Center
- The Care Group
- University of Iowa Hospitals and Clinics
- Cotton-O'Neil Clinical Research Center
- University of Maryland Hospital
- Tufts Medical Center
- Baystate Medical Center
- UMass Memorial Medical Center
- William Beaumont Hospital
- Michigan Cardiovascular Institute
- Minneapolis Heart Institute
- UMDNJ - Robert Wood Johnson Medical School
- University at Buffalo - Buffalo General Hospital
- Stony Brook University Medical Center
- Wake Forest University School of Medicine
- The Lindner Research Center
- The Ohio State University Medical Center
- Oregon Health & Science University
- Penn State University - Milton S. Hershey Medical Center
- Drexel University College of Medicine
- Allegheny General Hospital
- The Stern Cardiovascular Center
- Austin Heart P.A.
- University of Texas Health Science Center
- Fletcher Allen Health Care
- University of Wisconsin School of Medicine
- McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Prochymal®
Placebo
Participants will receive Prochymal® single intravenous (IV) infusion at a dose of 200 x 10^6 human mesenchymal stem cells (hMSC), reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.
Participants will receive Prochymal® placebo-matching single IV infusion at a dose of of 200 x 10^6 hMSC, reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.