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

NCT ID: NCT00877903

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-30
• Study Completion Date: 2016-03-14

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 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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Prochymal®

Intervention Type: DRUG

Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous infusion of excipients of Prochymal®

Interventions

Prochymal®

Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells

Intervention Type: DRUG

Placebo

Intravenous infusion of excipients of Prochymal®

Intervention Type: DRUG

Other Intervention Names

Remestemcel-L

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mesoblast, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ken Borow, MD

Role: STUDY_DIRECTOR

Mesoblast, Inc.

Locations

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

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

The Stern Cardiovascular Center

Germantown, Tennessee, United States

Austin Heart P.A.

Austin, Texas, United States

University of Texas Health Science Center

Houston, Texas, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

University of Wisconsin School of Medicine

Madison, Wisconsin, United States

McGill University Health Centre

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

403

Identifier Type: -

Identifier Source: org_study_id