Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH).
Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH).
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DOI：
10.1136/bmjopen-2021-053190
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发表时间：
2021-11-08
期刊：
影响因子：
2.9
通讯作者：
Forbes SJ
中科院分区：
文献类型：
--
作者：
Brennan PN;MacMillan M;Manship T;Moroni F;Glover A;Graham C;Semple S;Morris DM;Fraser AR;Pass C;McGowan NWA;Turner ML;Lachlan N;Dillon JF;Campbell JDM;Fallowfield JA;Forbes SJ
肝硬化是一个日益严峻的全球医疗保健挑战。肝硬化的特征是严重的肝纤维化、器官功能障碍和与门脉高压相关的并发症。目前还没有获得许可的抗纤维化或促再生药物，肝移植是一种稀缺资源。肝巨噬细胞可以促进肝纤维化的发生和纤维化的消退。外周输注离体成熟的自体单核细胞衍生的巨噬细胞在代偿性肝硬化患者中的安全性和可行性已得到证实。在一项多中心、开放标签、平行组、II期、随机对照试验中，将在代偿性肝硬化成人患者队列中研究自体巨噬细胞治疗与标准医疗护理相比的疗效。主要结局是90天时终末期肝病模型评分的变化。该试验将首次高质量地检测自体巨噬细胞治疗在改善代偿性肝硬化患者的肝功能、非侵入性纤维化标志物和其他临床结局方面的疗效。本试验将根据2013年赫尔辛基宣言的伦理原则进行，并已获得苏格兰A研究伦理委员会（参考文件15/SS/0121）、国家卫生服务洛锡安研究与开发部门和英国医药和医疗保健监管机构的批准。最终结果将在同行评审期刊和相关会议上发表。ISRCTN 10368050和EudraCT;参考2015-000963-15
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. 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. 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. ISRCTN10368050 and EudraCT; reference 2015-000963-15
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GMP兼容吞噬巨噬细胞生产的方法的发展，功能表征和验证：一种新型的细胞肝硬化细胞治疗。
影响因子：
4.5
作者：
Fraser AR;Pass C;Burgoyne P;Atkinson A;Bailey L;Laurie A;W A McGowan N;Hamid A;Moore JK;Dwyer BJ;Turner ML;Forbes SJ;Campbell JDM
通讯作者：
Campbell JDM
DOI：
10.1016/s2468-1253(17)30326-6
发表时间：
2018-01
期刊：
The lancet. Gastroenterology & hepatology
影响因子：
--
作者：
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通讯作者：
Forbes SJ
影响因子：
4.3
作者：
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通讯作者：
Fong, Daniel Yee Tak
影响因子：
25.7
作者：
Asrani, Sumeet K.;Devarbhavi, Harshad;Kamath, Patrick S.
通讯作者：
Kamath, Patrick S.
影响因子：
3.1
作者：
Kallman, Jillian;O'Neil, Mary Margaret;Younossi, Zobair M.
通讯作者：
Younossi, Zobair M.