Status:
COMPLETED
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Lead Sponsor:
Mesoblast, Inc.
Conditions:
Myocardial Infarction
Eligibility:
All Genders
21-85 years
Phase:
PHASE2
Brief Summary
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Detailed Description
The standard of care treatment for acute myocardial infarction (AMI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2016
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00877903
Start Date
March 30 2009
End Date
March 14 2016
Last Update
January 13 2022
Active Locations (33)
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1
Mercy Gilbert Medical Center / Catholic Health Care West
Gilbert, Arizona, United States, 85297
2
University of Arizona
Tucson, Arizona, United States, 85724
3
UC Davis Medical Center
Sacramento, California, United States, 95817
4
University of California - San Diego (UCSD)
San Diego, California, United States, 92103