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: study rationale and design.
Stem cell therapy has emerged as a promising approach to improve healing of the infarcted myocardium, to treat or prevent cardiac failure, and to restore lost cardiac function. Despite initial excitement, recent clinical trials using nonhomogenous human stem cells preparations showed variable results, raising concerns about the best cell type to transplant. Selected CD133(+) hematopoietic stem cells are promising candidate cells with great potential. COMPARE-acute myocardial infarction (AMI) study is a phase II, randomized, double-blind, placebo-controlled trial evaluating the safety and effectiveness of intracoronary CD133(+)-enriched hematopoietic bone marrow stem cells in patients with acute myocardial infarction and persistent left ventricular dysfunction. Patients who underwent successful percutaneous coronary intervention and present a persistent left ventricular ejection fraction <50% will be eligible to have bone marrow aspiration and randomized for intracoronary injection of selected CD 133(+) bone marrow cells vs placebo. The primary end point is a composite of a safety and efficacy end points evaluating the change at 4 months in the coronary atherosclerotic burden progression proximal and distal to the coronary stent in the infarct related artery; and the change in global left ventricular ejection fraction at 4 months relative to baseline as measured by magnetic resonance imaging. The secondary end point will be the occurrence of a major adverse cardiac event. To date, 14 patients were successfully randomized and treated without any protocol-related complication. COMPARE-AMI trial will help identify the effect of a selected population of the bone marrow stem cells on cardiac recovery of infarcted myocardium.
Mansour
Samer
S
Cardiology Department, Centre Hospitalier de l'Université de Montréal (CHUM), Hôtel Dieu, 3840, Rue Saint Urbain, Montreal, Québec, H2W 1T8, Canada. samer.mansour@sympatico.ca
Roy
Denis-Claude
DC
Bouchard
Vincent
V
Nguyen
Ba Khoi
BK
Stevens
Louis Mathieu
LM
Gobeil
Francois
F
Rivard
Alain
A
Leclerc
Guy
G
Reeves
François
F
Noiseux
Nicolas
N
D000071916:AC133 Antigen; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D015703:Antigens, CD / Q000032:analysis*; D001854:Bone Marrow Cells / Q000276:immunology*; D016026:Bone Marrow Transplantation; D004311:Double-Blind Method; D005260:Female; D006023:Glycoproteins / Q000032:analysis*; D018380:Hematopoietic Stem Cell Transplantation; D006412:Hematopoietic Stem Cells / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D009206:Myocardium / Q000473:pathology; D010455:Peptides / Q000032:analysis*; D020127:Recovery of Function; D012107:Research Design; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D016277:Ventricular Function, Left
D000071916:AC133 Antigen; D015703:Antigens, CD; D006023:Glycoproteins; C000606023:PROM1 protein, human; D010455:Peptides