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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
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

Tracking Information
First Submitted Date  ICMJE June 14, 2005
First Posted Date  ICMJE June 15, 2005
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE February 2005
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
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.
Change History Complete list of historical versions of study NCT00114452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Drug: Provacel
Study Arms  ICMJE Active Comparator: Provacel
ex vivo cultured adult mesenchymal stem cells
Intervention: Drug: Provacel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2012)
53
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
48
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00114452
Other Study ID Numbers  ICMJE 401
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mesoblast, Ltd. ( Mesoblast International Sàrl )
Study Sponsor  ICMJE Mesoblast International Sàrl
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua Hare, MD Johns Hopkins University
PRS Account Mesoblast, Ltd.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP