Document Detail


Rationale and design of Enhanced Angiogenic Cell Therapy in Acute Myocardial Infarction (ENACT-AMI): the first randomized placebo-controlled trial of enhanced progenitor cell therapy for acute myocardial infarction.
MedLine Citation:
PMID:  20211295     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Despite the widespread use of pharmacological and/or interventional reperfusion therapies, recovery of cardiac function in myocardial infarction (MI) patients is often modest or even absent. Unlike classical pharmacological treatments, the use of progenitor cells could potentially restore functional tissue in regions that otherwise would form only scar. However, a major limitation of autologous cell therapy is the deleterious influence of age and cardiac risk factors on progenitor cell activity. TRIAL DESIGN: The ENACT-AMI trial is a phase IIb, double-blind, randomized placebo-controlled trial, using transplantation of autologous early endothelial progenitor cells (EPCs) for patients who have suffered large MI. Circulating mononuclear cells (MNCs) are obtained by apheresis and subjected to differential culture for 3 days to select a population of highly regenerative, endothelial-like, culture modified MNCs (E-CMMs), often referred to as "early EPCs." A total of 99 patients will be randomized to placebo (Plasma-Lyte A), autologous E-CMMs, or E-CMMs transfected with human endothelial nitric oxide synthase delivered by coronary injection into the infarct-related artery. The primary efficacy end point is change from baseline to 6 months in global left ventricular ejection fraction by cardiac MRI; secondary endpoints include regional wall motion, wall thickening, infarct volume, time to clinical worsening, and quality of life. CONCLUSIONS: This will be the first clinical trial to include a strategy designed to enhance the function of autologous progenitor cells by overexpressing endothelial nitric oxide synthase, and the first to use combination gene and cell therapy for the treatment of cardiac disease.
Authors:
Monica Taljaard; Michael R Ward; Michael J B Kutryk; David W Courtman; Nancy J Camack; Shaun G Goodman; Thomas G Parker; Alexander J Dick; Jacques Galipeau; Duncan J Stewart
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  American heart journal     Volume:  159     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-03-09     Completed Date:  2010-04-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  354-60     Citation Subset:  AIM; IM    
Affiliation:
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada. mtaljaard@ohri.ca
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MeSH Terms
Descriptor/Qualifier:
Double-Blind Method
Humans
Myocardial Infarction / surgery*
Nitric Oxide Synthase Type III / genetics,  metabolism*
Research Design*
Stem Cell Transplantation*
Stem Cells / enzymology*
Transfection
Transplantation, Autologous
Up-Regulation
Chemical
Reg. No./Substance:
EC 1.14.13.39/Nitric Oxide Synthase Type III

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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