Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction
1 other identifier
interventional
220
2 countries
33
Brief Summary
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Longer than P75 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2009
CompletedFirst Submitted
Initial submission to the registry
April 7, 2009
CompletedFirst Posted
Study publicly available on registry
April 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2016
CompletedMarch 11, 2026
November 1, 2025
2.1 years
April 7, 2009
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
Baseline, Month 3
Secondary Outcomes (11)
Left Ventricular End Systolic Volume
6 months
Infarct Size
3 and 6 months
Left Ventricular Ejection Fraction
3 and 6 months
Left Ventricular End Diastolic Volume
3 and 6 months
Number of Participants with Ventricular Arrhythmias
3 and 6 months
- +6 more secondary outcomes
Study Arms (2)
Prochymal®
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Inc.lead
Study Sites (33)
Mercy Gilbert Medical Center / Catholic Health Care West
Gilbert, Arizona, 85297, United States
University of Arizona
Tucson, Arizona, 85724, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of California - San Diego (UCSD)
San Diego, California, 92103, United States
University of Miami
Miami, Florida, 33136, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The Care Group
Indianapolis, Indiana, 46290, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66604, United States
University of Maryland Hospital
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, 48601, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
University at Buffalo - Buffalo General Hospital
Buffalo, New York, 14203, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
The Lindner Research Center
Cincinnati, Ohio, 45219, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Penn State University - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
The Stern Cardiovascular Center
Germantown, Tennessee, 38138, United States
Austin Heart P.A.
Austin, Texas, 78756, United States
University of Texas Health Science Center
Houston, Texas, 77030, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
University of Wisconsin School of Medicine
Madison, Wisconsin, 53792, United States
McGill University Health Centre
Montreal, Quebec, H3A 1A1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ken Borow, MD
Mesoblast, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2009
First Posted
April 8, 2009
Study Start
March 30, 2009
Primary Completion
May 18, 2011
Study Completion
March 14, 2016
Last Updated
March 11, 2026
Record last verified: 2025-11