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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00114452
Recruitment Status : Completed
First Posted : June 15, 2005
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Provacel Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2005
Primary Completion Date : October 2006
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Provacel
ex vivo cultured adult mesenchymal stem cells
Drug: Provacel

Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114452

United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, California
University of California - San Diego; Thornton
San Diego, California, United States, 92103-8411
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
The Care Group
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Washington Adventist
Takoma Park, Maryland, United States, 20912
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
University of Rochester - Strong Memorial
Rochester, New York, United States, 14642
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Austin Heart Institute
Austin, Texas, United States, 78756
Texas Medical School
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mesoblast International Sàrl
Principal Investigator: Joshua Hare, MD Johns Hopkins University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00114452     History of Changes
Other Study ID Numbers: 401
First Posted: June 15, 2005    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
Acute Myocardial Infarction
Heart Attack
Cardiovascular Disease
Stem cells
Congestive Heart Failure
Heart Attack Repair

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases