title: A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trial†.
abstract: OBJECTIVE
  Clinical trials suggest that intracoronary delivery of autologous bone marrow-derived cells (BMCs) 1-7 days post-acute myocardial infarction (AMI) may improve left ventricular (LV) function. Earlier time points have not been evaluated. We sought to determine the effect of intracoronary autologous BMC on LV function when delivered within 24 h of successful reperfusion therapy.
  
  
  RESULTS
  A multi-centre phase II randomized, double-blind, and placebo-controlled trial. One hundred patients with anterior AMI and significant regional wall motion abnormality were randomized to receive either intracoronary infusion of BMC or placebo (1:1) within 24 h of successful primary percutaneous intervention (PPCI). The primary endpoint was the change in left ventricular ejection fraction (LVEF) between baseline and 1 year as determined by advanced cardiac imaging. At 1 year, although LVEF increased compared with baseline in both groups, the between-group difference favouring BMC was small (2.2%; 95% confidence interval, CI: -0.5 to 5.0; P = 0.10). However, there was a significantly greater myocardial salvage index in the BMC-treated group compared with placebo (0.1%; 95% CI: 0.0-0.20; P = 0.048). Major adverse events were rare in both treatment groups.
  
  
  CONCLUSIONS
  The early infusion of intracoronary BMC following PPCI for patients with AMI and regional wall motion abnormality leads to a small non-significant improvement in LVEF when compared with placebo; however, it may play an important role in infarct remodelling and myocardial salvage.
authors.affiliation: Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
authors.forename: Fizzah
authors.initials: F
authors.lastname: Choudry
authors.affiliation: Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hamshere
authors.affiliation: Stem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Natalie
authors.initials: N
authors.lastname: Saunders
authors.affiliation: Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
authors.forename: Jessry
authors.initials: J
authors.lastname: Veerapen
authors.affiliation: Institute of Cardiovascular Science, University College London, The Heart Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, UK.
authors.forename: Katrine
authors.initials: K
authors.lastname: Bavnbek
authors.affiliation: Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Knight
authors.affiliation: Institute of Cardiovascular Science, University College London, The Heart Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, UK.
authors.forename: Denis
authors.initials: D
authors.lastname: Pellerin
authors.affiliation: Service de Cardiologie et Département de Médecine Interne, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: Didier
authors.initials: D
authors.lastname: Locca
authors.affiliation: Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Westwood
authors.affiliation: Department of Cardiology, The Royal Free Hospital, Royal Free London Foundation Trust, London, UK.
authors.forename: Roby
authors.initials: R
authors.lastname: Rakhit
authors.affiliation: Institute of Cardiovascular Science, University College London, The Heart Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, UK.
authors.forename: Tom
authors.initials: T
authors.lastname: Crake
authors.affiliation: Department of Cardiology, Rigshopitale, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Kastrup
authors.affiliation: Cancer Division, Medical Research Council Clinical Trials Unit, London, UK.
authors.forename: Mahesh
authors.initials: M
authors.lastname: Parmar
authors.affiliation: Stem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Samir
authors.initials: S
authors.lastname: Agrawal
authors.affiliation: Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Jones
authors.affiliation: British Heart Foundation Laboratories, Department of Medicine, University College London, London WC1E 6JJ, UK.
authors.forename: John
authors.initials: J
authors.lastname: Martin
authors.affiliation: Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, UK Barts Health NIHR Cardiovascular Biomedical Research Unit, Barts Health NHS Trust, London EC1A 7BE, UK a.mathur@qmul.ac.uk.
authors.forename: Anthony
authors.initials: A
authors.lastname: Mathur
mesh_terms: D056988:Anterior Wall Myocardial Infarction / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D016026:Bone Marrow Transplantation / Q000379:methods*; D000072226:Computed Tomography Angiography; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000378:metabolism; D010446:Peptide Fragments / Q000378:metabolism; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011788:Quality of Life; D016879:Salvage Therapy / Q000379:methods; D013318:Stroke Volume / Q000502:physiology; D014182:Transplantation, Autologous; D018487:Ventricular Dysfunction, Left / Q000175:diagnosis
chemical_list: D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain
keywords: Acute myocardial infarction; Cardiac magnetic resonance imaging; Primary percutaneous coronary intervention; Stem cell therapy