Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH)
Autor: | Thomas Manship, Mark T. Macmillan, Francesca Moroni, John M. Campbell, Paul Noel Brennan, Alison Glover, Alasdair R. Fraser, John F. Dillon, Stuart J. Forbes, Neil W. A. McGowan, Neil Lachlan, David M. Morris, Marc Turner, Chloe Pass, Jonathan A. Fallowfield, Catriona Graham, Scott Semple |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Liver Cirrhosis
medicine.medical_specialty Cirrhosis medicine.medical_treatment Gastroenterology and Hepatology Liver transplantation Severity of Illness Index State Medicine hepatobiliary disease law.invention End Stage Liver Disease immunology Liver disease Clinical Trials Phase II as Topic Randomized controlled trial law Internal medicine cell biology Medicine Humans Multicenter Studies as Topic Randomized Controlled Trials as Topic clinical trials business.industry Macrophages Research Organ dysfunction Hepatobiliary disease General Medicine medicine.disease Clinical trial Treatment Outcome Liver function medicine.symptom business |
Zdroj: | BMJ Open, Vol 11, Iss 11 (2021) BMJ Open Brennan, P N, MacMillan, M, Manship, T, Moroni, F, Glover, A, Graham, C, Semple, S, Morris, D M, Fraser, A R, Pass, C, McGowan, N W A, Turner, M L, Lachlan, N, Dillon, J F, Campbell, J D M, Fallowfield, J A & Forbes, S J 2021, ' Study Protocol: A multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH) ', BMJ Open . https://doi.org/DOI: 10.1136/bmjopen-2021-053190 |
ISSN: | 2044-6055 |
Popis: | IntroductionLiver 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 analysisThe 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 disseminationThe 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 numbersISRCTN10368050 and EudraCT; reference 2015-000963-15 |
Databáze: | OpenAIRE |
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