Mejoría funcional en pacientes con miocardiopatía dilatada tras la infusión intracoronaria de células mononucleares autólogas de la médula ósea

Lezo, José Suárez de; Herrera, Concepción; Romero, Miguel; Pan, Manuel; Lezo, Javier Suárez de; Carmona, M. D. Ruiz; Jiménez, Rosario; Segura, José; Nogueras, Sonia; Mesa, Dolores; Pavlovic, Djordje; Ojeda, Soledad; Mazuelos, Francisco; Delgado, Mónica; Ruiz, Martín; Castilla, María Luisa Dotor; Torres, Antonio

doi:10.1016/j.recesp.2012.11.014

Cited by 6 publications

(5 citation statements)

References 33 publications

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“…The disease is associated with adverse outcomes, including a 20% 5-year mortality related with heart failure. Recent studies have shown that intracoronary infusion of autologous BMMNCs has a positive impact in the cardiac function of affected patients [22–29, 32, 41], but until now there are not reported studies assessing the safety and efficacy of high dose BMMNCs (5–10 × 10 8 cells), for a follow-up period longer than one year. Other published trials evaluating the use of BMMNCs in idiopathic DC have a limited sample size, are not controlled or blinded.…”

Section: Discussionmentioning

confidence: 99%

“…Angiographic changes in global LVEF at 6 months after cell infusion is the primary endpoint of the trial. Cardiac catheterization is performed to measure systemic and left ventricular end-diastolic pressure, left ventricular function, and coronary flow reserve for each coronary artery as previously published [32]. The left ventricular function studies are based on the analysis of at least one left ventricular angiogram at a 30° right anterior oblique projection.…”

Section: Methods and Designmentioning

confidence: 99%

“…However, non-responders to a previously implanted defibrillator can be included. In the pilot study performed by our group an inverse correlation was found among basal high-density lipoprotein (HDL) serum levels and LVEF improvement (r = − 0,41, p = 0,03) [32]. Consequently, patients with a lower baseline values of HDL could attain a higher improvement in LVEF.…”

Section: Methods and Designmentioning

confidence: 99%

“…A sample size calculation was performed based on the clinical trial study already completed by our group [32]. In this study, a mean increase in ejection fraction of 9.4 ± 9.9% was observed.…”

Section: Methods and Designmentioning

confidence: 99%

“…More recently, these results have been confirmed by the REGENERATE-DCM clinical trial [30], in which a 5.37% increase in left ventricular ejection fraction (LVEF) was observed at 3 months after treatment with autologous BM-derived cells combined with peripheral granulocyte colony-stimulating factor (G-CSF). Next to these previous experiences, our group has completed a one-year Phase II Clinical Trial (NCT00629096, EudraCT 2007–003088-36) to evaluate the safety and efficacy of intracoronary infusion of autologous BMMNCs in 27 patients with DC [32]. In this study, an improvement in the New York Heart Association (NYHA) functional class and a reduction of brain natriuretic peptide (BNP) plasma levels were observed without any adverse effect.…”

Section: Introductionmentioning

confidence: 99%

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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

Romero

Suárez-de-Lezo

Herrera

et al. 2019

BMC Cardiovasc Disord

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Background 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.

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