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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00114452
First received: June 14, 2005
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Provacel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: February 2005
Study Completion Date: February 2009
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Provacel
ex vivo cultured adult mesenchymal stem cells
Drug: Provacel

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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114452

Locations
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
Osiris Therapeutics
Investigators
Principal Investigator: Joshua Hare, MD Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT00114452     History of Changes
Other Study ID Numbers: 401
Study First Received: June 14, 2005
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:
Acute Myocardial Infarction
Heart Attack
Cardiovascular Disease
Stem cells
Congestive Heart Failure
Heart Attack Repair

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

ClinicalTrials.gov processed this record on November 24, 2014