Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH).
BMJ Open
; 11(11): e053190, 2021 11 08.
Article
in En
| MEDLINE
| ID: mdl-34750149
ABSTRACT
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 ANDANALYSIS:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
End Stage Liver Disease
Type of study:
Clinical_trials
/
Guideline
/
Prognostic_studies
Aspects:
Ethics
Limits:
Humans
Language:
En
Journal:
BMJ Open
Year:
2021
Document type:
Article
Affiliation country:
Reino Unido