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One-Year Safety Analysis of the COMPARE-AMI Trial: Comparison of Intracoronary Injection of CD133+ Bone Marrow Stem Cells to Placebo in Patients after Acute Myocardial Infarction and Left Ventricular Dysfunction.Bone Marrow Res. 2011
Myocardial Infarction and Left Ventricular Dysfunction
Samer Mansour, 1, 2 * Denis-Claude Roy, 3 Vincent Bouchard, 4 Louis Mathieu Stevens, 2, 5 Francois Gobeil, 1 Alain Rivard, 1, 2 Guy Leclerc, 1 François Reeves, 1, 2 and Nicolas Noiseux 2, 5 *
1Division de Cardiologie, Département de Médecine, Centre Hospitalier de l'Université de Montréal (CHUM), 3840, Rue Saint Urbain, Montréal, Québec, Canada H2W 1T8
2Axe Cardio-Métabolique, Centre de Recherche du CHUM (CRCHUM), Montréal, Québec, Canada H2W 1T7
3Département d'Hématologie, Hôpital Maisonneuve-Rosemont (HMR), Montréal, Québec, Canada H1T 2M4
4Faculté de Médicine, Université de Montréal, Montréal, Québec, Canada H3C 3J7
5Division de Chirurgie Cardiaque, Département de Chirurgie, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Québec, Canada H2W 1T8
*Samer Mansour: Email: samer.mansour@sympatico.ca and
*Nicolas Noiseux: Email: noiseuxn@videotron.ca
Academic Editor: Mark R. Litzow
Received August 22, 2010; Accepted December 12, 2010.
This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
* Other Sections?
o Abstract
o 1. Introduction
o 2. Methods
o 3. Results
o 4. Discussion
o References
Abstract
Bone marrow stem cell therapy has emerged as a promising approach to improve healing of the infarcted myocardium. Despite initial excitement, recent clinical trials using non-homogenous stem cells preparations showed variable and mixed results. Selected CD133+ hematopoietic stem cells are candidate cells with high potential. Herein, we report the one-year safety analysis on the initial 20 patients enrolled in the COMPARE-AMI trial, the first double-blind randomized controlled trial comparing the safety, efficacy, and functional effect of intracoronary injection of selected CD133+ cells to placebo following acute myocardial infarction with persistent left ventricular dysfunction. At one year, there is no protocol-related complication to report such as death, myocardial infarction, stroke, or sustained ventricular arrhythmia. In addition, the left ventricular ejection fraction significantly improved at four months as compared to baseline and remained significantly higher at one year. These data indicate that in the setting of the COMPARE-AMI trial, the intracoronary injection of selected CD133+ stem cells is secure and feasible in patients with left ventricle dysfunction following acute myocardial infarction.
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