Cell therapy for heart disease: Trial sequential analyses of two cochrane reviews

Clinical Pharmacology and Therapeutics
Sheila A FisherEnca Martin-Rendon

Abstract

Meta-analyses of cell therapy trials for heart disease have yielded discrepant results. To resolve limitations associated with meta-analyses, such as imprecision and accumulation of random errors, we have conducted trial sequential analysis (TSA). Randomised controlled trials which administered autologous bone marrow-derived cells to patients who suffered acute myocardial infarction (AMI) or heart failure (HF) were included. TSA has been applied to two clinical outcomes, all-cause mortality and hospitalisation for HF, and to left ventricular ejection fraction (LVEF), as surrogate of heart function. The results suggest that there is evidence of reduction of the risk of mortality and hospitalisation in HF, but insufficient evidence to determine treatment effect in AMI. Moreover, the treatment does not improve LVEF by more than a mean difference of 4% when administered to either AMI or HF patients. The required number of participants to include in a meta-analysis to detect treatment effect has also been estimated. This article is protected by copyright. All rights reserved.

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Citations

Apr 10, 2016·Lancet·Amit N PatelUNKNOWN ixCELL-DCM Investigators
Aug 20, 2016·Journal of Cardiovascular Translational Research·Arne A N BruyneelCarolyn Carr
Oct 28, 2016·Apoptosis : an International Journal on Programmed Cell Death·Lucian BeerHendrik Jan Ankersmit
Feb 27, 2017·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Patrizia NigroGiulio Pompilio
Jul 28, 2017·Nature Reviews. Cardiology·Robert A KlonerJianru Shi
Dec 25, 2016·The Cochrane Database of Systematic Reviews·Sheila A FisherEnca Martin-Rendon
Jul 7, 2018·Circulation Research·Eugene Braunwald
Jul 7, 2018·Circulation Research·Mariann GyöngyösiEnca Martin Rendon
May 11, 2018·Nature Reviews. Cardiology·Philippe Menasché
Jan 1, 2018·Nature Biomedical Engineering·Philippe Menasché
Oct 12, 2016·Clinical Pharmacology and Therapeutics·G CastelliniC Gluud
Dec 22, 2017·Clinical Pharmacology and Therapeutics·Scott A Waldman, Andre Terzic
Apr 4, 2021·Cells·Thomas J Povsic, Bernard J Gersh
Jul 22, 2021·The Cochrane Database of Systematic Reviews·Rienzi Diaz-NavarroEva Madrid

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