NCT00114452

Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction

A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose Escalation, Multicenter Study to Determine the Safety of Intravenous Ex-vivo Cultured Adult Human Mesenchymal Stem Cells (Provacel) Following Acute Myocardial Infarction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mesoblast, Inc. · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether adult stem cells \[Provacel™(PUMP1)\] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).

Detailed description

Cardiovascular disease is the single largest killer of males and females in the United States with an average of 335,000 deaths per year. This year an estimated 700,000 Americans will suffer an acute myocardial infarction. The standard of care treatment for acute myocardial infarction (MI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. Management of cardiac risk factors such as tobacco use, hypertension, lipid levels, diabetes, weight control and exercise all work to reduce further atherosclerotic events. Yet, many patients go on to develop Congestive Heart Failure (CHF). Medical management for CHF may improve symptoms and slow the progression to failure but does not 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 in an area of unmet medical need. Patients will receive standard of care in addition to stem cells or placebo.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	Provacel	ex vivo cultured adult mesenchymal stem cells
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2005-03-22
• Primary completion: 2006-10-04
• Completion: 2008-04-24
• First posted: 2005-06-15
• Last updated: 2020-03-10

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study