1. 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
- Author
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Miguel Romero, José Suárez-de-Lezo, Concha Herrera, Manuel Pan, José López-Aguilera, Flor Baeza-Garzón, Francisco Javier Hidalgo-Lesmes, Olga Fernández-López, Juliana Martínez-Atienza, Eva Cebrián, Vanesa Martín-Palanco, Rosario Jiménez-Moreno, Rosario Gutiérrez-Fernández, Sonia Nogueras, Maria Dolores Carmona, Soledad Ojeda, Natividad Cuende, Rosario Mata, [Romero,M, Suárez-de-Lezo, 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., and This 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).
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Male ,lcsh:Diseases of the circulatory (Cardiovascular) system ,Time Factors ,Ensayo clínico controlado aleatorio ,030204 cardiovascular system & hematology ,Cell therapy ,Ventricular Function, Left ,law.invention ,Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] ,Study Protocol ,Cardiomiopatía dilatada ,0302 clinical medicine ,Randomized controlled trial ,law ,Dilated myocardiopathy ,Multicenter Studies as Topic ,030212 general & internal medicine ,Myocardial infarction ,Diseases::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Cardiomyopathy, Dilated [Medical Subject Headings] ,Bone Marrow Transplantation ,Randomized Controlled Trials as Topic ,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 Topic [Medical Subject Headings] ,Diseases::Cardiovascular Diseases::Vascular Diseases::Myocardial Ischemia::Myocardial Infarction [Medical Subject Headings] ,Ejection fraction ,Middle Aged ,Treatment Outcome ,Disciplines and Occupations::Natural Science Disciplines::Science::Research::Biomedical Research [Medical Subject Headings] ,Female ,Cardiology and Cardiovascular Medicine ,Adult ,Cardiomyopathy, Dilated ,medicine.medical_specialty ,Information Science::Information Science::Communications Media::Publications [Medical Subject Headings] ,Adolescent ,Cell- and tissue-based therapy ,Células de la médula ósea ,Bone Marrow Cells ,Placebo ,Transplantation, Autologous ,Young Adult ,03 medical and health sciences ,Clinical Trials, Phase II as Topic ,Double-Blind Method ,Tratamiento basado en trasplante de células y tejidos ,Internal medicine ,medicine ,Humans ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy [Medical Subject Headings] ,Aged ,Angiology ,Anatomy::Cells::Bone Marrow Cells [Medical Subject Headings] ,business.industry ,Consolidated Standards of Reporting Trials ,Recovery of Function ,medicine.disease ,Interim analysis ,Clinical trial ,lcsh:RC666-701 ,Spain ,Bone marrow mononuclear cells ,business - Abstract
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. 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. The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comite Coordinador de Etica en Investigacion Biomedica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Espanola 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. 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.
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- 2019