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Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial

Thompson, J; Jones, N; Al-Khafaji, A; Malik, S; Reich, D; Munoz, S; MacNicholas, R; ... VTI-208 Study Group, .; + view all (2018) Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial. Liver Transplantation , 24 (3) pp. 380-393. 10.1002/lt.24986. Green open access

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Abstract

Severe Alcoholic Hepatitis (sAH) is associated with a poor prognosis. There is no proven effective treatment for sAH, which is why early transplantation has been increasingly discussed. Hepatoblastoma-derived C3A cells express anti-inflammatory proteins and growth factors and were tested in an extracorporeal liver treatment (ELAD) study to establish their effect on survival for subjects with sAH. Adults with sAH, bilirubin ≥8 mg/dL, Maddrey's Discriminant Function (DF) ≥32 and Model for End-Stage Liver Disease (MELD) score ≤35, were randomized to receive standard of care (SOC) only or 3-5 days of continuous ELAD treatment plus SOC. After a minimum follow-up of 91 days, overall survival (OS) was assessed using a Kaplan-Meier survival analysis. A total of 203 subjects were enrolled (96 ELAD and 107 SOC) at 40 sites worldwide. Comparison of baseline characteristics showed no significant differences between groups and within subgroups. There was no significant difference in serious adverse events between the two groups. In an analysis of the intent-to-treat (ITT) population, there was no difference in OS (51.0% vs 49.5%). The study failed its primary and secondary endpoint in a population with AAH and with a MELD ranging from 18-35 and no upper age limit. In the pre-specified analysis of subjects with MELD <28 (n=120), ELAD was associated with a trend toward higher OS at 91 days (68.6% vs 53.6%, p=0.077). Regression analysis identified high creatinine and INR, but not bilirubin, as the MELD components predicting negative outcomes with ELAD. A new trial investigating a potential benefit of ELAD in younger subjects with sufficient renal function and less severe coagulopathy has been initiated.

Type: Article
Title: Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/lt.24986
Publisher version: http://doi.org/10.1002/lt.24986
Language: English
Additional information: Copyright © 2017 The Authors. Liver Transplantation published by Wiley Periodicals, Inc. on behalf of American Association for the Study of Liver Diseases. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
Keywords: Acute Alcoholic Hepatitis, Bioartificial Liver Support, C3A cell line, Multi Organ Failure
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inst for Liver and Digestive Hlth
URI: http://discovery.ucl.ac.uk/id/eprint/10039305
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