title: Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial.
abstract: BACKGROUND
  The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by post-infarction left-ventricular (LV) dysfunction. Our aim was to investigate the effect of autologous bone marrow-derived stem cell (BMSC) transfer in the infarct-related artery on LV function and structure.
  
  
  METHODS
  We did a randomised, double-blind, placebo-controlled study in 67 patients from whom we harvested bone marrow 1 day after successful percutaneous coronary intervention for STEMI. We assigned patients optimum medical treatment and infusion of placebo (n=34) or BMSC (n=33). Our primary endpoint was the increase in LV ejection fraction and our secondary endpoints were change in infarct size and regional LV function at 4 months' follow-up, all assessed by MRI. We assessed changes in myocardial perfusion and oxidative metabolism with serial 1-[11C]acetate PET. Analyses were per protocol. This study is registered with , number NCT00264316.
  
  
  RESULTS
  Mean global LV ejection fraction 4 days after percutaneous coronary intervention was 46.9% (SD 8.2) in controls and 48.5% (7.2) in BMSC patients, and increased after 4 months to 49.1% (10.7) and 51.8% (8.8; OR for treatment effect 1.036, 95% CI 0.961-1.118, p=0.36). Compared with placebo infusion, BMSC transfer was associated with a significant reduction in myocardial infarct size (BMSC treatment effect 28%, p=0.036) and a better recovery of regional systolic function. Myocardial perfusion and metabolism increased similarly in both groups. We noted no complications associated with BMSC transfer and all but one patient in the BMSC group completed the 4 months' follow-up.
  
  
  CONCLUSIONS
  Intracoronary transfer of autologous bone marrow cells within 24 h of optimum reperfusion therapy does not augment recovery of global LV function after myocardial infarction, but could favourably affect infarct remodelling.
authors.affiliation: Department of Cardiology, Gasthuisberg University Hospital, University of Leuven, Leuven, Belgium. Stefan.Janssens@uz.kuleuven.ac.be
authors.forename: Stefan
authors.initials: S
authors.lastname: Janssens
authors.forename: Christophe
authors.initials: C
authors.lastname: Dubois
authors.forename: Jan
authors.initials: J
authors.lastname: Bogaert
authors.forename: Koen
authors.initials: K
authors.lastname: Theunissen
authors.forename: Christophe
authors.initials: C
authors.lastname: Deroose
authors.forename: Walter
authors.initials: W
authors.lastname: Desmet
authors.forename: Maria
authors.initials: M
authors.lastname: Kalantzi
authors.forename: Lieven
authors.initials: L
authors.lastname: Herbots
authors.forename: Peter
authors.initials: P
authors.lastname: Sinnaeve
authors.forename: Joseph
authors.initials: J
authors.lastname: Dens
authors.forename: Johan
authors.initials: J
authors.lastname: Maertens
authors.forename: Frank
authors.initials: F
authors.lastname: Rademakers
authors.forename: Steven
authors.initials: S
authors.lastname: Dymarkowski
authors.forename: Olivier
authors.initials: O
authors.lastname: Gheysens
authors.forename: Johan
authors.initials: J
authors.lastname: Van Cleemput
authors.forename: Guy
authors.initials: G
authors.lastname: Bormans
authors.forename: Johan
authors.initials: J
authors.lastname: Nuyts
authors.forename: Ann
authors.initials: A
authors.lastname: Belmans
authors.forename: Luc
authors.initials: L
authors.lastname: Mortelmans
authors.forename: Marc
authors.initials: M
authors.lastname: Boogaerts
authors.forename: Frans
authors.initials: F
authors.lastname: Van de Werf
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D001854:Bone Marrow Cells; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000628:therapy*; D033581:Stem Cell Transplantation / Q000379:methods*; D018487:Ventricular Dysfunction, Left / Q000209:etiology / Q000628:therapy*; D020257:Ventricular Remodeling