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Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions

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ClinicalTrials.gov Identifier: NCT00264316
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : January 17, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to determine whether intracoronary transfer of bone marrow cells will augment left ventricular function recovery of the heart.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: bone marrow-derived stem cell transfer Phase 2

Detailed Description:

Despite early coronary reperfusion, salvage of ischemic myocardium is incomplete and loss of viable myocardium initiates a process of adverse left ventricular (LV) remodeling1, compromising clinical outcome.

Experimental data have suggested that autologous bone marrow-derived or circulating progenitor cells may be beneficial for LV function recovery, but underlying mechanisms are unclear and prominent cardiomyocyte transdifferentiation has only been reported under selected experimental conditions. Early non-randomized clinical investigations indicate feasibility, safety and enhanced functional recovery after autologous human bone marrow-derived stem cell (BMSC) infusion into the infarct-related artery. More recently, a randomized open study demonstrated improvement of LV systolic function but not of LV remodeling following BMSC transfer.

In the absence of trials, in which the control group reproduces the exact conditions of the cell transfer group, including bone marrow aspiration and a placebo intracoronary injection, the true benefit of cell transfer cannot be fully appreciated.

We, therefore, designed a randomized, double-blind, and placebo-controlled exploratory study to investigate the effect of autologous BMSC transfer on LV functional and structural recovery after myocardial infarction. In view of the exploratory nature of the study and to detect potential mechanisms for the biological effect, we also assessed myocardial perfusion and oxidative metabolism using serial 1-[11C]acetate positron emission tomography (PET).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Official Title: A Double-blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.
Study Start Date : May 2003
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months

Secondary Outcome Measures :
  1. change in infarct size and regional LV function; evaluation by magnetic resonance (MRI) after 4 months
  2. change in myocardial perfusion and oxidative metabolism; investigated using serial 1-[11C]acetate positron emission tomography after 4 months

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with acute myocardial infarction with cumulative ST-segment elevation >=6mm, successful epicardial reperfusion after PCI and significant LV dysfunction

Exclusion Criteria:

  • patients presenting within 2 hours of symptom onset (no dilution of any treatment effect from aborted infarctions)
  • patients with prior coronary artery bypass grafting, pulmonary edema, cardiogenic shock or significant co-morbidities
Contacts and Locations

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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): NCT00264316


Locations
Belgium
Department of Cardiology, University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Stefan Janssens, MD, PhD Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
Study Director: Frans Van de Werf, MD, PhD Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00264316     History of Changes
Other Study ID Numbers: SJ-CAR-ML2170
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: December 2005

Keywords provided by Universitaire Ziekenhuizen Leuven:
bone marrow cell transfer
acute myocardial infarction
left ventricular function

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