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The purpose of the study is to determine whether adult stem cells [Provacelâ„¢(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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provacel: Cohort 1 | Active Comparator | ex vivo cultured adult mesenchymal stem cells |
|
| Provacel: Cohort 2 | Active Comparator | ex vivo cultured adult mesenchymal stem cells |
|
| Provacel: Cohort 3 | Active Comparator | ex vivo cultured adult mesenchymal stem cells |
|
| Provacel: Cohort 4 | Active Comparator | ex vivo cultured adult mesenchymal stem cells |
|
| Placebo | Placebo Comparator | ex vivo cultured adult mesenchymal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provacel | Biological | ex vivo cultured adult mesenchymal stem cells |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Borow, MD | Mesoblast, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Institute | Phoenix | Arizona | 85006 | United States | ||
| University of California - San Diego; Thornton |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12480809 | Background | Orlic D, Hill JM, Arai AE. Stem cells for myocardial regeneration. Circ Res. 2002 Dec 13;91(12):1092-102. doi: 10.1161/01.res.0000046045.00846.b0. | |
| 15242981 | Background | Pittenger MF, Martin BJ. Mesenchymal stem cells and their potential as cardiac therapeutics. Circ Res. 2004 Jul 9;95(1):9-20. doi: 10.1161/01.RES.0000135902.99383.6f. |
| Label | URL |
|---|---|
| Click here for more information about heart disease | View source |
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| Placebo | Biological | Placebo |
|
| San Diego |
| California |
| 92103-8411 |
| United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| The Care Group | Indianapolis | Indiana | 46260 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Washington Adventist | Takoma Park | Maryland | 20912 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Columbia Presbyterian Hospital | New York | New York | 10032 | United States |
| University of Rochester - Strong Memorial | Rochester | New York | 14642 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Austin Heart Institute | Austin | Texas | 78756 | United States |
| Texas Medical School | Houston | Texas | 77030 | United States |
| 12078791 | Background | Shake JG, Gruber PJ, Baumgartner WA, Senechal G, Meyers J, Redmond JM, Pittenger MF, Martin BJ. Mesenchymal stem cell implantation in a swine myocardial infarct model: engraftment and functional effects. Ann Thorac Surg. 2002 Jun;73(6):1919-25; discussion 1926. doi: 10.1016/s0003-4975(02)03517-8. |
| 19958962 | Derived | Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055. |
| Click here for more information about this study and adult mesenchymal stem cells. | View source |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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