Myocardial Infarction Clinical Trial
Official title:
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
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).
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.
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