NCT00877903

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Mesoblast, Inc. · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Prochymal®	Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
DRUG	Placebo	Intravenous infusion of excipients of Prochymal®

Timeline

• Start date: 2009-03-30
• Primary completion: 2011-05-18
• Completion: 2016-03-14
• First posted: 2009-04-08
• Last updated: 2026-03-11

Locations

33 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study