Study Protocol: A multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH)

Paul Noel Brennan*, Mark MacMillan, Tom Manship, Francesca Moroni, Alison Glover, Catriona Graham, Scott Semple, David M Morris, Alasdair R Fraser, Chloe Pass, Neil W A McGowan, Marc L Turner, Neil Lachlan, John F Dillon, John D M Campbell, Jonathan Andrew Fallowfield, Stuart J Forbes

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

Introduction Liver cirrhosis is a growing global healthcare challenge. Cirrhosis is characterised by severe liver fibrosis, organ dysfunction and complications related to portal hypertension. There are no licensed antifibrotic or proregenerative medicines and liver transplantation is a scarce resource. Hepatic macrophages can promote both liver fibrogenesis and fibrosis regression. The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.

Methods and analysis The efficacy of autologous macrophage therapy, compared with standard medical care, will be investigated in a cohort of adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, phase 2, randomised controlled trial. The primary outcome is the change in Model for End-Stage Liver Disease score at 90 days. The trial will provide the first high-quality examination of the efficacy of autologous macrophage therapy in improving liver function, non-invasive fibrosis markers and other clinical outcomes in patients with compensated cirrhosis.

Ethics and dissemination The trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by Scotland A Research Ethics Committee (reference 15/SS/0121), National Health Service Lothian Research and Development department and the Medicine and Health Care Regulatory Agency-UK. Final results will be presented in peer-reviewed journals and at relevant conferences.
Original languageEnglish
JournalBMJ Open
DOIs
Publication statusPublished - 8 Nov 2021

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