Multicentre, Randomized, Double-Blind Trial of Intracoronary Autologous Mononuclear Bone Marrow Cell Injection in Non-Ischaemic Dilated Cardiomyopathy (The Dilated Cardiomyopathy Arm of the MiHeart Study)
Multicentre, Randomized, Double-Blind Trial of Intracoronary Autologous Mononuclear Bone Marrow Cell Injection in Non-Ischaemic Dilated Cardiomyopathy (The Dilated Cardiomyopathy Arm of the MiHeart Study)
Data
2015
Autores
Martino, Helena
Brofman, Paulo
Greco, Oswaldo
Bueno, Ronaldo
Bodanese, Luiz
Clausell, Nadine
Maldonado, Jaime Arnez
Mill, José
Braile, Domingo
Moraes Jr, João
Journal Title
Journal ISSN
Volume Title
Publisher
European Heart Journal
Resumo
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. Therewere 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.
Description
Palavras-chave
Terapia Baseada em Transplante de Células e Tecidos, Células-tronco, Insuficiência cardíaca, Cardiomiopatias, Tissue therapy, Stem cells, Heart failure, Cardiomyopathy
Citação
Martino H, Brofman P, Greco O, Bueno R, Bodanese L, Clausell N et al. Multicentre, Randomized, Double-Blind Trial of Intracoronary Autologous Mononuclear Bone Marrow Cell Injection in Non-Ischaemic Dilated Cardiomyopathy (The Dilated Cardiomyopathy Arm of the MiHeart Study). Eur Heart J. 2015 Nov 7;36(42):2898-904. doi: 10.1093/eurheartj/ehv477.