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

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

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Prochymal®; Drug: Placebo

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 Ace-inhibitors. However, because salvaging the viable myocardium is dependent on early reperfusion, only a minority of participants will reach the hospital within the time-window for myocardial rescue. Thus, even if the participant manages their tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many participants will go on to develop Congestive Heart Failure (CHF). Though the medical management for CHF may improve symptoms and slow disease progression, such treatment cannot restore a functioning myocardium. A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of CHF following acute MI would provide a significant benefit. The characteristics and biologic activity of Prochymal®, along with a good safety profile in human trials to date, suggest that Prochymal® may be a good candidate for addressing this unmet medical need.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill University Health Centre
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Mercy Gilbert Medical Center / Catholic Health Care West
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • San Diego, California, United States, 92103
      • University of California - San Diego (UCSD)
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • The Care Group
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Topeka, Kansas, United States, 66604
      • Cotton-O'Neil Clinical Research Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Saginaw, Michigan, United States, 48601
      • Michigan Cardiovascular Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • UMDNJ - Robert Wood Johnson Medical School
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo - Buffalo General Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University - Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Center
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart P.A.
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prochymal®; 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.	Drug: Prochymal®; Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells; Other Names: Remestemcel-L
Placebo Comparator: Placebo; 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.	Drug: Placebo; Intravenous infusion of excipients of Prochymal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3	Baseline, Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		60 months
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
Duke Activity Status Index (DASI) Assessment	The Duke Activity Status Index (DASI) is a brief, self-administered questionnaire that provides a standardized assessment of functional status and quality-of-life that correlates well with an objective measure of maximal exercise capacity. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores indicate a greater ability to perform daily activities.	6, 12, and 24 months
New York Heart Association (NYHA) Congestive Heart Failure Classification Status		6, 12, 24, and 60 months
Maximal Symptom-limited Exercise Test (Treadmill)		6 and 12 months
Number of Participants with Major Adverse Cardiac Events (MACE)		6, 12, 24, and 60 months
Number of Participants with Adverse Events		3,6,12,24,60 months

Collaborators and Investigators

• Sponsor: Mesoblast, Inc.
• Investigators: Study Director: Ken Borow, MD, Mesoblast, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2009
• Primary Completion (Actual): May 18, 2011
• Study Completion (Actual): March 14, 2016

Study Registration Dates

• First Submitted: April 7, 2009
• First Submitted That Met QC Criteria: April 7, 2009
• First Posted (Estimated): April 8, 2009

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Myocardial infarction; AMI; Mesenchymal stem cells; MSC; Acute myocardial infarction; Heart attack; Osiris; Adult human stem cells
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Anti-Infective Agents; Antiviral Agents; Anti-Inflammatory Agents; remestemcel-l
• Other Study ID Numbers: 403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No