The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction : rationale and design of the trial
Mathur, Anthony (Queen Mary University of London)
Arnold, Roman (Hospital Clínico Universitario de Valladolid)
Assmus, Birgit (Johann-Wolfgang-Goethe University (Germany))
Bartunek, Jozef (VZW Cardiovascular Research Center Aalst (Belgium))
Belmans, Ann (KU Leuven-University of Leuven & Universiteit Hasselt (Belgium))
Bönig, Halvard (Johann-Wolfgang-Goethe University (Germany))
Crea, Filippo (Catholic University of the Sacred Heart (Italy))
Dimmeler, Stefanie (Johann-Wolfgang-Goethe University (Germany))
Dowlut, Sheik (Queen Mary University of London)
Fernández Avilés, F. (Hospital General Universitario Gregorio Marañón)
Galiñanes, Manuel (Hospital Universitari Vall d'Hebron)
García-Dorado, David (Hospital Universitari Vall d'Hebron)
Hartikainen, Juha (Kuopio University Hospital ( Finlàndia))
Hill, Jonathan (King's College Hospital NHS Foundation Trust)
Hogardt-Noll, Annette (t2cure (Germany))
Homsy, Christian (Celyad SA (Belgium))
Janssens, Stefan (University Hospitals Leuven (Bèlgica))
Kala, Petr (Faculty Hospital and Masaryk University (Czech Republic))
Kastrup, Jens (University of Copenhagen)
Martin, John (University College London (UK))
Menasche, Philippe (University Paris Descartes. Assistance Publique Hopitaux de Paris (France))
Miklik, Roman (Faculty Hospital and Masaryk University (Czech Republic))
Mozid, Abdul (Barts Heart Centre (UK))
San Román, J. Alberto (Hospital Clínico Universitario de Valladolid)
Sanz-Ruiz, Ricardo (Hospital General Universitario Gregorio Marañón)
Tendera, Michal (Medical University of Silesia (Poland))
Wojakowski, Wojtek (Medical University of Silesia (Poland))
Ylä-Herttuala, Seppo (Kuopio University Hospital ( Finlàndia))
Zeiher, Andreas Michael (Johann-Wolfgang-Goethe University (Germany))
Universitat Autònoma de Barcelona

Date:	2017
Abstract:	Over the past 13 years bone marrow-derived mononuclear cells () have been widely investigated for clinical efficacy in patients following acute myocardial infarction (). These early phase trials have used various surrogate markers to judge efficacy and, although promising, the results have been inconsistent. The phase trial has therefore been designed to demonstrate that intracoronary infusion of is safe and will significantly reduce the time to first occurrence of all-cause death in patients with reduced left ventricular ejection fraction after successful reperfusion for -elevation (powered with the aim of detecting a 25% reduction in all-cause mortality). This is a multinational, multicentre, randomized, open-label, controlled, parallel-group phase study aiming to enrol approximately 3000 patients in 11 European countries with at least 17 sites. Eligible patients who have impaired left ventricular ejection (≤45%) following successful reperfusion for will be randomized to treatment or control group in a 1:1 ratio. The treatment group will receive intracoronary infusion of 2-8 days after successful reperfusion for added on top of optimal standard of care. The control group will receive optimal standard of care. The primary endpoint is time from randomization to all-cause death. The trial is pivotal and the largest trial to date of in patients with impaired left ventricular function following . The aim of the trial is to provide a definitive answer as to whether reduce all-cause mortality in this group of patients.
Grants:	European Commission 278967
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Cell therapy ; Cardiovascular disease ; Bone marrow-derived mononuclear cells ; Myocardial infarction ; Heart failure ; Cardiac regeneration
Published in:	European Journal of Heart Failure, Vol. 19, Issue 11 (November 2017) , p. 1545-1550, ISSN 1879-0844

DOI: 10.1002/ejhf.829
PMID: 28948706

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