Romero, MiguelSuárez-de-Lezo, JoséHerrera, ConchaPan, ManuelLópez-Aguilera, JoséSuárez-de-Lezo Jr, JoséBaeza-Garzón, FlorHidalgo-Lesmes, Francisco JavierFernández-López, OlgaMartínez-Atienza, JulianaCebrián, EvaMartín-Palanco, VanesaJiménez-Moreno, RosarioGutiérrez-Fernández, RosarioNogueras, SoniaCarmona, Maria DoloresOjeda, SoledadCuende, NatividadMata, Rosario2020-05-152020-05-152019-08-22Romero 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/s12872-019-1182-41471-2261http://hdl.handle.net/10668/3115Background 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 ClinicalTrials.gov Identifier NCT02033278 (First Posted January 10, 2014): https://clinicaltrials.gov/ct2/show/NCT02033278; EudraCT number: 2013–002015-98, EU CT Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002015-98. Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.enBone marrow mononuclear cellsCell therapyDilated myocardiopathyRandomized controlled trialBone Marrow CellsCell- and tissue-based therapyCardiomyopathy, DilatedCélulas de la médula óseaTratamiento basado en trasplante de células y tejidosCardiomiopatía dilatadaEnsayo clínico controlado aleatorioMedical Subject Headings::Anatomy::Cells::Bone Marrow CellsMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Cell- and Tissue-Based TherapyMedical Subject Headings::Diseases::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Cardiomyopathy, DilatedMedical 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 TopicMedical Subject Headings::Disciplines and Occupations::Natural Science Disciplines::Science::Research::Biomedical ResearchMedical Subject Headings::Diseases::Cardiovascular Diseases::Vascular Diseases::Myocardial Ischemia::Myocardial InfarctionMedical Subject Headings::Information Science::Information Science::Communications Media::Publicationsresearch article31438858open access10.1186/s12872-019-1182-4PMC6704590