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

December 9, 2005
January 16, 2013
May 2003
Not Provided
increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
Same as current
Complete list of historical versions of study NCT00264316 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions
A Double-blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Myocardial Infarction
Procedure: bone marrow-derived stem cell transfer
Not Provided
Janssens S, Dubois C, Bogaert J, Theunissen K, Deroose C, Desmet W, Kalantzi M, Herbots L, Sinnaeve P, Dens J, Maertens J, Rademakers F, Dymarkowski S, Gheysens O, Van Cleemput J, Bormans G, Nuyts J, Belmans A, Mortelmans L, Boogaerts M, Van de Werf F. Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial. Lancet. 2006 Jan 14;367(9505):113-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
December 2005
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00264316
SJ-CAR-ML2170
Not Provided
Not Provided
Universitaire Ziekenhuizen Leuven
Not Provided
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
Universitaire Ziekenhuizen Leuven
December 2005

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