RT Journal Article
T1 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
A1 Romero, Miguel
A1 Suárez-de-Lezo, José
A1 Herrera, Concha
A1 Pan, Manuel
A1 López-Aguilera, José
A1 Suárez-de-Lezo Jr, José
A1 Baeza-Garzón, Flor
A1 Hidalgo-Lesmes, Francisco Javier
A1 Fernández-López, Olga
A1 Martínez-Atienza, Juliana
A1 Cebrián, Eva
A1 Martín-Palanco, Vanesa
A1 Jiménez-Moreno, Rosario
A1 Gutiérrez-Fernández, Rosario
A1 Nogueras, Sonia
A1 Carmona, Maria Dolores
A1 Ojeda, Soledad
A1 Cuende, Natividad
A1 Mata, Rosario
K1 Bone marrow mononuclear cells
K1 Cell therapy
K1 Dilated myocardiopathy
K1 Randomized controlled trial
K1 Bone Marrow Cells
K1 Cell- and tissue-based therapy
K1 Cardiomyopathy, Dilated
K1 Células de la médula ósea
K1 Tratamiento basado en trasplante de células y tejidos
K1 Cardiomiopatía dilatada
K1 Ensayo clínico controlado aleatorio
AB BackgroundCellular 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.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.
PB BioMed Central
SN 1471-2261
YR 2019
FD 2019-08-22
LK http://hdl.handle.net/10668/3115
UL http://hdl.handle.net/10668/3115
LA en
NO Romero 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/s12872-019-1182-4
DS RISalud
RD Apr 8, 2025