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Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions
This study has been completed.
Sponsored by: University Hospital, Gasthuisberg
Information provided by: University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00264316
  Purpose

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 Intervention Phase
Myocardial Infarction
Procedure: bone marrow-derived stem cell transfer
Phase II

MedlinePlus related topics: Heart Attack
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Double-Blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.

Further study details as provided by University Hospital, Gasthuisberg:

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

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

Estimated Enrollment: 68
Study Start Date: May 2003
Estimated Study Completion Date: December 2005
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with acute myocardial infarction with cumulative ST-segement elevation >=6mm, succesful 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264316

Locations
Belgium
Department of Cardiology, University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
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

Website Department of Cardiology, KULeuven  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: SJ-CAR-ML2170
Study First Received: December 9, 2005
Last Updated: May 8, 2006
ClinicalTrials.gov Identifier: NCT00264316  
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by University Hospital, Gasthuisberg:
bone marrow cell transfer
acute myocardial infarction
left ventricular function

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009