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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877903
• Other study ID #: 403
• Status: Completed
• Phase: Phase 2
• Start date: March 30, 2009
• Est. completion date: March 14, 2016

Study information

• Verified date: January 2022
• Source: Mesoblast, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 14, 2016
• Est. primary completion date: May 18, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Prochymal®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
• Placebo
Intravenous infusion of excipients of Prochymal®

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec
United States	Austin Heart P.A.	Austin	Texas
United States	University of Maryland Hospital	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	University at Buffalo - Buffalo General Hospital	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Rush University Medical Center	Chicago	Illinois
United States	The Lindner Research Center	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	The Stern Cardiovascular Center	Germantown	Tennessee
United States	Mercy Gilbert Medical Center / Catholic Health Care West	Gilbert	Arizona
United States	Penn State University - Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas Health Science Center	Houston	Texas
United States	The Care Group	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Wisconsin School of Medicine	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	UC Davis Medical Center	Sacramento	California
United States	Michigan Cardiovascular Institute	Saginaw	Michigan
United States	University of California - San Diego (UCSD)	San Diego	California
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	University of Arizona	Tucson	Arizona
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3		Baseline, Month 3
Secondary	Left Ventricular End Systolic Volume		6 months
Secondary	Infarct Size		3 and 6 months
Secondary	Left Ventricular Ejection Fraction		3 and 6 months
Secondary	Left Ventricular End Diastolic Volume		3 and 6 months
Secondary	Number of Participants with Ventricular Arrhythmias		3 and 6 months
Secondary	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
Secondary	New York Heart Association (NYHA) Congestive Heart Failure Classification Status		6, 12, 24, and 60 months
Secondary	Maximal Symptom-limited Exercise Test (Treadmill)		6 and 12 months
Secondary	Number of Participants with Major Adverse Cardiac Events (MACE)		6, 12, 24, and 60 months
Secondary	Overall Survival		60 months
Secondary	Number of Participants with Adverse Events		3,6,12,24,60 months