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dc.contributor.authorRomero, Miguel-
dc.contributor.authorSuárez-de-Lezo, José-
dc.contributor.authorHerrera, Concha-
dc.contributor.authorPan, Manuel-
dc.contributor.authorLópez-Aguilera, José-
dc.contributor.authorSuárez-de-Lezo Jr, José-
dc.contributor.authorBaeza-Garzón, Flor-
dc.contributor.authorHidalgo-Lesmes, Francisco Javier-
dc.contributor.authorFernández-López, Olga-
dc.contributor.authorMartínez-Atienza, Juliana-
dc.contributor.authorCebrián, Eva-
dc.contributor.authorMartín-Palanco, Vanesa-
dc.contributor.authorJiménez-Moreno, Rosario-
dc.contributor.authorGutiérrez-Fernández, Rosario-
dc.contributor.authorNogueras, Sonia-
dc.contributor.authorCarmona, Maria Dolores-
dc.contributor.authorOjeda, Soledad-
dc.contributor.authorCuende, Natividad-
dc.contributor.authorMata, Rosario-
dc.identifier.citationRomero M, Suárez-de-Lezo J, Herrera C, Pan M, López-Aguilera J, Suárez-de-Lezo Jr J, et al. Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol. BMC Cardiovasc Disord. 2019 Aug 22;19(1):203. doi: 10.1186/s12872-019-1182-4es_ES
dc.description.abstractBackground Cellular therapies have been increasingly applied to diverse human diseases. Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction. However, less information is available about the role of BMMNC therapy for the treatment of dilated myocardiopathies (DCs) of non-ischemic origin. This article presents the methodological description of a study aimed at investigating the efficacy of intracoronary injection of autologous BMMNCs in the improvement of the ventricular function of patients with DC. Methods This randomised, placebo-controlled, double-blinded phase IIb clinical trial compares the improvement on ventricular function (measured by the changes on the ejection fraction) of patients receiving the conventional treatment for DC in combination with a single dose of an intracoronary infusion of BMMNCs, with the functional recovery of patients receiving placebo plus conventional treatment. Patients assigned to both treatment groups are monitored for 24 months. This clinical trial is powered enough to detect a change in Left Ventricular Ejection Fraction (LVEF) equal to or greater than 9%, although an interim analysis is planned to re-calculate sample size. Discussion The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comité Coordinador de Ética en Investigación Biomédica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), and is registered at the EU Clinical Trials Register (EudraCT: 2013–002015-98). The publication of the trial results in scientific journals will be performed in accordance with the applicable regulations and guidelines to clinical trials. Trial registration Identifier NCT02033278 (First Posted January 10, 2014):; EudraCT number: 2013–002015-98, EU CT Register: Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.es_ES
dc.description.sponsorshipThis paper presents an investigator-driven Clinical trial partially funded by research grant provided by the Regional Ministry of Health of Andalusia (Grant Reference Number salud-201600073587-tra).es_ES
dc.format.extent12 p.es_ES
dc.publisherBioMed Centrales_ES
dc.relation.ispartofBMC cardiovascular disorderses_ES
dc.subjectBone marrow mononuclear cellses_ES
dc.subjectCell therapyes_ES
dc.subjectDilated myocardiopathyes_ES
dc.subjectRandomized controlled triales_ES
dc.subjectBone Marrow Cellses_ES
dc.subjectCell- and tissue-based therapyes_ES
dc.subjectCardiomyopathy, Dilatedes_ES
dc.subjectCélulas de la médula óseaes_ES
dc.subjectTratamiento basado en trasplante de células y tejidoses_ES
dc.subjectCardiomiopatía dilatadaes_ES
dc.subjectEnsayo clínico controlado aleatorioes_ES
dc.subject.meshMedical Subject Headings::Anatomy::Cells::Bone Marrow Cellses_ES
dc.subject.meshMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humanses_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapyes_ES
dc.subject.meshMedical Subject Headings::Diseases::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Cardiomyopathy, Dilatedes_ES
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topices_ES
dc.subject.meshMedical Subject Headings::Disciplines and Occupations::Natural Science Disciplines::Science::Research::Biomedical Researches_ES
dc.subject.meshMedical Subject Headings::Diseases::Cardiovascular Diseases::Vascular Diseases::Myocardial Ischemia::Myocardial Infarctiones_ES
dc.subject.meshMedical Subject Headings::Information Science::Information Science::Communications Media::Publicationses_ES
dc.titleRandomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocoles_ES
dc.rights.accessRightsAcceso abiertoes_ES
dc.contributor.authoraffiliation[Romero,M; Suárez-de-Lezo;J; Pan,M; López-Aguilera,J; Suárez-de-Lezo Jr,J; Baeza-Garzón,F; Hidalgo-Lesmes,FJ; Cebrián,E; Ojeda,S] Cardiology Unit, Reina Sofía University Hospital, Córdoba, Spain. [Herrera,C; Martín-Palanco,V; Jiménez-Moreno,R; Gutiérrez-Fernández,R; Nogueras,S; Carmona,MD] Cell Production Unit, Reina Sofía University Hospital, Córdoba, Spain. [Fernández-López,O; Martínez-Atienza,J; Cuende,N; Mata,R] Andalusian Initiative for Advanced Therapies, Andalusian Public Foundation Progress and Health, Seville, Spain.es_ES
dc.type.subtypeArtículo originales_ES
Appears in Collections:01- Artículos - Hospital Reina Sofía
01- Artículos - Red Andaluza de Diseño y Traslación de Terapias Avanzadas

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