PMID- 26405233
OWN - NLM
STAT- MEDLINE
DCOM- 20170109
LR  - 20170220
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 37
IP  - 3
DP  - 2016 Jan 14
TI  - A randomized double-blind control study of early intra-coronary autologous bone
      marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical 
      trialdagger.
PG  - 256-63
LID - 10.1093/eurheartj/ehv493 [doi]
AB  - AIMS: 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. METHODS
      AND 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. CONCLUSION: 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.
CI  - (c) The Author 2015. Published by Oxford University Press on behalf of the
      European Society of Cardiology.
FAU - Choudry, Fizzah
AU  - Choudry F
AD  - Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West
      Smithfield, London EC1A 7BE, UK.
FAU - Hamshere, Stephen
AU  - Hamshere S
AD  - Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West
      Smithfield, London EC1A 7BE, UK.
FAU - Saunders, Natalie
AU  - Saunders N
AD  - Stem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary
      University of London, London, UK.
FAU - Veerapen, Jessry
AU  - Veerapen J
AD  - Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West
      Smithfield, London EC1A 7BE, UK.
FAU - Bavnbek, Katrine
AU  - Bavnbek K
AD  - Institute of Cardiovascular Science, University College London, The Heart
      Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, UK.
FAU - Knight, Charles
AU  - Knight C
AD  - Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West
      Smithfield, London EC1A 7BE, UK.
FAU - Pellerin, Denis
AU  - Pellerin D
AD  - Institute of Cardiovascular Science, University College London, The Heart
      Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, UK.
FAU - Locca, Didier
AU  - Locca D
AD  - Service de Cardiologie et Departement de Medecine Interne, Centre Hospitalier
      Universitaire Vaudois, Lausanne, Switzerland.
FAU - Westwood, Mark
AU  - Westwood M
AD  - Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West
      Smithfield, London EC1A 7BE, UK.
FAU - Rakhit, Roby
AU  - Rakhit R
AD  - Department of Cardiology, The Royal Free Hospital, Royal Free London Foundation
      Trust, London, UK.
FAU - Crake, Tom
AU  - Crake T
AD  - Institute of Cardiovascular Science, University College London, The Heart
      Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, UK.
FAU - Kastrup, Jens
AU  - Kastrup J
AD  - Department of Cardiology, Rigshopitale, University of Copenhagen, Copenhagen,
      Denmark.
FAU - Parmar, Mahesh
AU  - Parmar M
AD  - Cancer Division, Medical Research Council Clinical Trials Unit, London, UK.
FAU - Agrawal, Samir
AU  - Agrawal S
AD  - Stem Cell Laboratory, Barts Health NHS Trust and Blizard Institute, Queen Mary
      University of London, London, UK.
FAU - Jones, Daniel
AU  - Jones D
AD  - Department of Cardiology, St Bartholomew's Hospital, Barts Health NHS Trust, West
      Smithfield, London EC1A 7BE, UK.
FAU - Martin, John
AU  - Martin J
AD  - British Heart Foundation Laboratories, Department of Medicine, University College
      London, London WC1E 6JJ, UK.
FAU - Mathur, Anthony
AU  - Mathur A
AD  - 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.
LA  - eng
SI  - EudraCT/2007-002144-16
SI  - ClinicalTrials.gov/NCT00765453
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20150923
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
RN  - 0 (Peptide Fragments)
RN  - 0 (pro-brain natriuretic peptide (1-76))
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
SB  - IM
CIN - Eur Heart J. 2016 Jan 14;37(3):264-6. PMID: 26453369
MH  - Anterior Wall Myocardial Infarction/pathology/physiopathology/*therapy
MH  - Bone Marrow Transplantation/*methods
MH  - Computed Tomography Angiography
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Magnetic Resonance Angiography
MH  - Male
MH  - Middle Aged
MH  - Natriuretic Peptide, Brain/metabolism
MH  - Peptide Fragments/metabolism
MH  - Percutaneous Coronary Intervention/methods
MH  - Quality of Life
MH  - Salvage Therapy/methods
MH  - Stroke Volume/physiology
MH  - Transplantation, Autologous
MH  - Ventricular Dysfunction, Left/diagnosis
PMC - PMC4712349
OTO - NOTNLM
OT  - Acute myocardial infarction
OT  - Cardiac magnetic resonance imaging
OT  - Primary percutaneous coronary intervention
OT  - Stem cell therapy
EDAT- 2015/09/26 06:00
MHDA- 2017/01/10 06:00
CRDT- 2015/09/26 06:00
PHST- 2015/04/29 00:00 [received]
PHST- 2015/08/27 00:00 [accepted]
PHST- 2015/09/26 06:00 [entrez]
PHST- 2015/09/26 06:00 [pubmed]
PHST- 2017/01/10 06:00 [medline]
AID - ehv493 [pii]
AID - 10.1093/eurheartj/ehv493 [doi]
PST - ppublish
SO  - Eur Heart J. 2016 Jan 14;37(3):256-63. doi: 10.1093/eurheartj/ehv493. Epub 2015
      Sep 23.