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Sponsored by: |
University Hospital, Gasthuisberg |
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Information provided by: | University Hospital, Gasthuisberg |
ClinicalTrials.gov Identifier: | NCT00264316 |
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 |
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Myocardial Infarction |
Procedure: bone marrow-derived stem cell transfer |
Phase II |
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. |
Estimated Enrollment: | 68 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | 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).
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Department of Cardiology, University Hospital Gasthuisberg | |
Leuven, Belgium, 3000 |
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 |
Study ID Numbers: | SJ-CAR-ML2170 |
Study First Received: | December 9, 2005 |
Last Updated: | May 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00264316 History of Changes |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
bone marrow cell transfer acute myocardial infarction left ventricular function |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |