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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Biological: Provacel
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 21 and 85 years old First heart attack within 1 to 10 days Exclusion Criteria: Positive for HIV 1 and 2 Previous heart attack Pacemaker or other device Pregnant or breastfeeding Allergic to cow or pig derived products Previous bone marrow transplant Involved in another clinical trial within the past 30 days Alcohol or recreational drug abuse within the past 6 months Hepatitis Positive Major surgical procedure or major trauma within the past 14 days Body weight greater than 300 pounds Autoimmune disease ( e.g. Lupus, Multiple Sclerosis)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Provacel: Cohort 1<br>ex vivo cultured adult mesenchymal stem cells | Biological: Provacel<br>* ex vivo cultured adult mesenchymal stem cells<br>|
| Active Comparator: Provacel: Cohort 2<br>ex vivo cultured adult mesenchymal stem cells | Biological: Provacel<br>* ex vivo cultured adult mesenchymal stem cells<br>|
| Active Comparator: Provacel: Cohort 3<br>ex vivo cultured adult mesenchymal stem cells | Biological: Provacel<br>* ex vivo cultured adult mesenchymal stem cells<br>|
| Active Comparator: Provacel: Cohort 4<br>ex vivo cultured adult mesenchymal stem cells | Biological: Provacel<br>* ex vivo cultured adult mesenchymal stem cells<br>|
| Placebo Comparator: Placebo<br>ex vivo cultured adult mesenchymal stem cells | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myocardial Infarction, Heart Attack, Cardiovascular Disease, Stem cells, Congestive Heart Failure, Heart Attack Repair