- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264316
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- Department of Cardiology, University Hospital Gasthuisberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
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Secondary Outcome Measures
Outcome Measure |
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change in infarct size and regional LV function; evaluation by magnetic resonance (MRI) after 4 months
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change in myocardial perfusion and oxidative metabolism; investigated using serial 1-[11C]acetate positron emission tomography after 4 months
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Collaborators and Investigators
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJ-CAR-ML2170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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