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Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions

This study has been completed.
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00264316
First received: December 9, 2005
Last updated: January 16, 2013
Last verified: December 2005
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Official Title: A Double-blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

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-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
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: 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00264316     History of Changes
Other Study ID Numbers: SJ-CAR-ML2170
Study First Received: December 9, 2005
Last Updated: January 16, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

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 19, 2014