Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions/
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Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions
This study is no longer recruiting patients.
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
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 Outcomes: increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
Secondary Outcomes: 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
Expected Total Enrollment: 68
Study start: May 2003
Last follow-up: December 2005
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 - 75 Years, Genders Eligible for Study: Both
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
Location Information
Belgium
Department of Cardiology, University Hospital Gasthuisberg, Leuven, 3000, Belgium
Study chairs or principal investigators
Stefan Janssens, MD, PhD, Principal Investigator, Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
Frans Van de Werf, MD, PhD, Study Director, Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
More Information
Study ID Numbers: SJ-CAR-ML2170
Last Updated: December 9, 2005
Record first received: December 9, 2005
ClinicalTrials.gov Identifier: NCT00264316
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
ClinicalTrials.gov processed this record on 2006-01-13 |
