The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction

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 inco...

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Detalles Bibliográficos
Autores: Mathur, Anthony|||0000-0001-7941-9653, Arnold, Roman, Assmus, Birgit, Bartunek, Jozef, Belmans, Ann, Bönig, Halvard|||0000-0003-0088-2675, Crea, Filippo|||0000-0001-9404-8846, Dimmeler, Stefanie, Dowlut, Sheik, Fernández Avilés, Francisco|||0000-0001-5501-5275, Galiñanes, Manuel|||0000-0002-0888-976X, García-Dorado, David|||0000-0002-1126-1279, Hartikainen, Juha|||0000-0003-0847-107X, Hill, Jonathan, Hogardt-Noll, Annette, Homsy, Christian, Janssens, Stefan, Kala, Petr, Kastrup, Jens|||0000-0002-3668-5393, Martin, John, Menasche, Philippe, Miklik, Roman, Mozid, Abdul, San Román, José Alberto|||0000-0003-0764-0839, Sanz-Ruiz, Ricardo, Tendera, Michal, Wojakowski, Wojtek|||0000-0002-3681-5207, Ylä-Herttuala, Seppo|||0000-0001-7593-2708, Zeiher, Andreas Michael|||0000-0003-1711-5819
Tipo de recurso: artículo
Fecha de publicación:2017
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:210787
Acceso en línea:https://ddd.uab.cat/record/210787
https://dx.doi.org/urn:doi:10.1002/ejhf.829
Access Level:acceso abierto
Palabra clave:Cell therapy
Cardiovascular disease
Bone marrow-derived mononuclear cells
Myocardial infarction
Heart failure
Cardiac regeneration
Descripción
Sumario: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.

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