Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction
- Conditions
- Myocardial Infarction
- Interventions
- Biological: ProvacelBiological: Placebo
- Registration Number
- NCT00114452
- Lead Sponsor
- Mesoblast, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Male or female between 21 and 85 years old
- First heart attack within 1 to 10 days
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Provacel: Cohort 1 Provacel ex vivo cultured adult mesenchymal stem cells Provacel: Cohort 3 Provacel ex vivo cultured adult mesenchymal stem cells Placebo Placebo ex vivo cultured adult mesenchymal stem cells Provacel: Cohort 2 Provacel ex vivo cultured adult mesenchymal stem cells Provacel: Cohort 4 Provacel ex vivo cultured adult mesenchymal stem cells
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Washington Adventist
🇺🇸Takoma Park, Maryland, United States
Columbia Presbyterian Hospital
🇺🇸New York, New York, United States
Austin Heart Institute
🇺🇸Austin, Texas, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Care Group
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Texas Medical School
🇺🇸Houston, Texas, United States
Arizona Heart Institute
🇺🇸Phoenix, Arizona, United States
University of California - San Diego; Thornton
🇺🇸San Diego, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Rochester - Strong Memorial
🇺🇸Rochester, New York, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States