Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction
NCT ID: NCT00114452
Last Updated: 2020-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2005-03-22
2008-04-24
Brief Summary
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Detailed Description
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Patients will receive standard of care in addition to stem cells or placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Provacel: Cohort 1
ex vivo cultured adult mesenchymal stem cells
Provacel
ex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 2
ex vivo cultured adult mesenchymal stem cells
Provacel
ex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 3
ex vivo cultured adult mesenchymal stem cells
Provacel
ex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 4
ex vivo cultured adult mesenchymal stem cells
Provacel
ex vivo cultured adult mesenchymal stem cells
Placebo
ex vivo cultured adult mesenchymal stem cells
Placebo
Placebo
Interventions
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Provacel
ex vivo cultured adult mesenchymal stem cells
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* First heart attack within 1 to 10 days
Exclusion Criteria
* 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)
21 Years
85 Years
ALL
No
Sponsors
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Mesoblast, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ken Borow, MD
Role: STUDY_DIRECTOR
Mesoblast, Inc.
Locations
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Arizona Heart Institute
Phoenix, Arizona, United States
University of California - San Diego; Thornton
San Diego, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Rush University Medical Center
Chicago, Illinois, United States
The Care Group
Indianapolis, Indiana, United States
Jewish Hospital
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington Adventist
Takoma Park, Maryland, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Columbia Presbyterian Hospital
New York, New York, United States
University of Rochester - Strong Memorial
Rochester, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Austin Heart Institute
Austin, Texas, United States
Texas Medical School
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
Related Links
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Click here for more information about heart disease
Click here for more information about this study and adult mesenchymal stem cells.
Other Identifiers
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401-402
Identifier Type: -
Identifier Source: org_study_id
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