Helena Martino1, Paulo Brofman2, Oswaldo Greco3, Ronaldo Bueno4, Luiz Bodanese5, Nadine Clausell6, Jaime Arnez Maldonado7, José Mill8, Domingo Braile9, João Moraes10, Suzana Silva11, Augusto Bozza1, Braulio Santos1, Antonio Campos de Carvalho12. 1. Instituto Nacional de Cardiologia, Rua das Laranjeiras, 374/5° andar (Pesquisa Clínica), Rio de Janeiro, RJ CEP 22240-006, Brazil. 2. Santa Casa de Misericórdia do Paraná, Curitiba, Brazil. 3. Instituto de Moléstias Cardiovasculares, São José do Rio Preto, Brazil. 4. Universidade Federal do Paraná, Curitiba, Brazil. 5. Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil. 6. Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. 7. Universidade Federal do Amazonas, Manaus, Brazil. 8. Universidade Federal do Espírito Santo, Vitória, Brazil. 9. Instituto Domingo Braile, São José do Rio Preto, Brazil. 10. Hospital Agamenon Magalhães, Recife, Brazil. 11. Hospital Pró-Cardíaco, Rio de Janeiro, Brazil. 12. Instituto Nacional de Cardiologia, Rua das Laranjeiras, 374/5° andar (Pesquisa Clínica), Rio de Janeiro, RJ CEP 22240-006, Brazil acarlos@biof.ufrj.br.
Abstract
AIMS: Pre-clinical and few clinical studies suggest that transplantation of autologous bone marrow mononuclear cells (BMNC) improves heart function in dilated cardiomyopathies. Our objective was to determine if intracoronary injection of autologous BMNC improves the left ventricular ejection fraction (LVEF) of patients with non-ischaemic dilated cardiomyopathy (NIDCM). METHODS AND RESULTS: This study was a multicentre, randomized, double-blind, placebo controlled trial with a follow-up of 12 months. Patients with NIDCM and LVEF <35% were recruited at heart failure ambulatories in specialized hospitals around Brazil. One hundred and sixty subjects were randomized to intracoronary injection of BMNC or placebo (1:1). The primary endpoint was the difference in change of LVEF between BMNC and placebo groups as determined by echocardiography. One hundred and fifteen patients completed the study. Left ventricular ejection fraction decreased from 24.0% (21.6-26.3) to 19.9% (15.4-24.4) in the BMNC group and from 24.3% (22.1-26.5) to 22.1% (17.4-26.8) in the placebo group. There were no significant differences in changes between cell and placebo groups for left ventricular systolic and diastolic volumes and ejection fraction. Mortality rate was 20.37% in placebo and 21.31% in BMNC. CONCLUSION:Intracoronary injection of autologous BMNC does not improve left ventricular function in patients with NIDCM. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Pre-clinical and few clinical studies suggest that transplantation of autologous bone marrow mononuclear cells (BMNC) improves heart function in dilated cardiomyopathies. Our objective was to determine if intracoronary injection of autologous BMNC improves the left ventricular ejection fraction (LVEF) of patients with non-ischaemic dilated cardiomyopathy (NIDCM). METHODS AND RESULTS: This study was a multicentre, randomized, double-blind, placebo controlled trial with a follow-up of 12 months. Patients with NIDCM and LVEF <35% were recruited at heart failure ambulatories in specialized hospitals around Brazil. One hundred and sixty subjects were randomized to intracoronary injection of BMNC or placebo (1:1). The primary endpoint was the difference in change of LVEF between BMNC and placebo groups as determined by echocardiography. One hundred and fifteen patients completed the study. Left ventricular ejection fraction decreased from 24.0% (21.6-26.3) to 19.9% (15.4-24.4) in the BMNC group and from 24.3% (22.1-26.5) to 22.1% (17.4-26.8) in the placebo group. There were no significant differences in changes between cell and placebo groups for left ventricular systolic and diastolic volumes and ejection fraction. Mortality rate was 20.37% in placebo and 21.31% in BMNC. CONCLUSION: Intracoronary injection of autologous BMNC does not improve left ventricular function in patients with NIDCM. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Niall G Campbell; Masahiro Kaneko; Yasunori Shintani; Takuya Narita; Vinit Sawhney; Steven R Coppen; Kenta Yashiro; Anthony Mathur; Ken Suzuki Journal: PLoS One Date: 2016-07-05 Impact factor: 3.240
Authors: Elena Cambria; Francesco S Pasqualini; Petra Wolint; Julia Günter; Julia Steiger; Annina Bopp; Simon P Hoerstrup; Maximilian Y Emmert Journal: NPJ Regen Med Date: 2017-06-13
Authors: Rienzi Diaz-Navarro; Gerard Urrútia; John Gf Cleland; Daniel Poloni; Francisco Villagran; Roberto Acosta-Dighero; Shrikant I Bangdiwala; Gabriel Rada; Eva Madrid Journal: Cochrane Database Syst Rev Date: 2021-07-21