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Updated: Oct 14, 2025
A Simple and Efficient Method to Isolate Macrophages from Mixed Primary Cultures of Adult Liver Cells
Published on: May 24, 2011
Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous
Paul Noel Brennan1, Mark MacMillan2, Thomas Manship3
1Centre for Regenerative Medicine, The University of Edinburgh Medical School, Edinburgh, UK pbrenna2@ed.ac.uk.
Insights
This study investigates autologous macrophage therapy for liver cirrhosis. The phase 2 trial aims to improve liver function and fibrosis markers in patients with compensated cirrhosis.
Area of Science:
- Hepatology
- Immunology
- Regenerative Medicine
Background:
- Liver cirrhosis presents a significant global health challenge with limited treatment options.
- Current treatments for cirrhosis lack antifibrotic or proregenerative capabilities, and liver transplantation is scarce.
- Hepatic macrophages play a dual role in liver fibrogenesis and fibrosis regression.
Purpose of the Study:
- To evaluate the efficacy of autologous macrophage therapy in patients with compensated cirrhosis.
- To compare autologous macrophage therapy against standard medical care.
- To assess improvements in liver function, fibrosis markers, and clinical outcomes.
Main Methods:
- A multicentre, open-label, parallel-group, phase 2, randomised controlled trial.
- Involves adult patients with compensated cirrhosis.
- Primary outcome is the change in Model for End-Stage Liver Disease (MELD) score at 90 days.
Main Results:
- The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages have been demonstrated.
- This trial will provide high-quality evidence on the efficacy of this novel therapy.
- Further results on liver function and fibrosis markers are pending.
Conclusions:
- Autologous macrophage therapy shows promise as a novel treatment for liver cirrhosis.
- The study will offer crucial insights into improving liver function and mitigating fibrosis.
- This research addresses a critical unmet need in liver disease management.
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.
Trial Registration Numbers:
ISRCTN10368050 and EudraCT; reference 2015-000963-15.
