- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Leuven, Belgien, 3000
- Department of Cardiology, University Hospital Gasthuisberg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
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Sekundære resultatmål
Resultatmål |
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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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Stefan Janssens, MD, PhD, Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
- Studieleder: Frans Van de Werf, MD, PhD, Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SJ-CAR-ML2170
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