Overview

This trial is active, not recruiting.

Condition myocardial infarction
Treatments prochymal®, placebo
Phase phase 2
Sponsor Mesoblast International Sàrl
Start date March 2009
End date December 2011
Trial size 220 participants
Trial identifier NCT00877903, 403

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
prochymal®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
(Placebo Comparator)
placebo
Intravenous infusion of excipients of Prochymal®

Primary Outcomes

Measure
Left ventricular end systolic volume
time frame: 3 months

Secondary Outcomes

Measure
Left ventricular end systolic volume
time frame: 6 months
Infarct size
time frame: 3 and 6 months
Left ventricular ejection fraction
time frame: 3 and 6 months
Left ventricular end diastolic volume
time frame: 3 and 6 months
Incidence of ventricular arrhythmias
time frame: 3 and 6 months
Cardiovascular disease-specific quality of life (DASI) assessment
time frame: 6, 12, and 24 months
NYHA congestive heart failure classification status
time frame: 6, 12, 24, and 60 months
Maximal symptom-limited exercise test (treadmill)
time frame: 6 and 12 months
MACE endpoints
time frame: 6, 12, 24, and 60 months
Survival Status
time frame: 60 months
Adverse Event
time frame: 3,6,12,24,60 months

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

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 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.

Additional Information

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
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 patients will reach the hospital within the time-window for myocardial rescue. Thus, even if the patient manages their tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many patients 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Mesoblast, Ltd..