Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

Completed · Phase 2 · Has a placebo group

Conditions studied: Myocardial Infarction

In brief

The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.

Key facts

Study ID

NCT00877903

Run by

Mesoblast, Inc.

People needed

220

Starts

2009-03-30

Expected to finish

2016-03-14

Last updated by the study team

2026-03-11

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mercy Gilbert Medical Center / Catholic Health Care West — Gilbert, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of California - San Diego (UCSD) — San Diego, California, United States
• University of Miami — Miami, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The Care Group — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
• University of Maryland Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Michigan Cardiovascular Institute — Saginaw, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• UMDNJ - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• University at Buffalo - Buffalo General Hospital — Buffalo, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• The Lindner Research Center — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Penn State University - Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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