ThRIL;A 'first-in-human' study, evaluating the safety, tolerability with an investigation into the efficacy of Tregs in liver transplant recipients
ThRIL;一项“首次人体”研究,通过调查 Tregs 对肝移植受者的功效来评估安全性和耐受性
基本信息
- 批准号:MR/K025538/1
- 负责人:
- 金额:$ 260.28万
- 依托单位:
- 依托单位国家:英国
- 项目类别:Research Grant
- 财政年份:2013
- 资助国家:英国
- 起止时间:2013 至 无数据
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
Liver transplantation is a successful treatment for patients with severe liver disease. Despite this, the majority of patients are maintained on immunosuppressants (drugs that dampen down the immune system) life long with associated side effects, affecting the quality of life of the patient and the long term outcome. The aims of this study are, therefore, to i. determine if a new cell based therapy is safe and well tolerated in liver transplantation patients and ii. if immunosuppressive drugs can be withdrawn early after transplantation (once the patient has had this new therapy).The general aim of this therapy is to allow the withdrawal of immunosuppressants in patients receiving a liver transplant, with the ultimate goal of complete withdrawal of immunosuppressants lifelong.Interestingly, populations of immune cells in the recipient, called regulatory T cells, have been shown to regulate the patient's immune system and prevent against organ rejection. Our research is targeting at developing new treatments that involve increasing the number of these cells in the recipient. We will a. isolate these cells from the recipient at the time of transplant, expand them numerically and ensure they are stable in culture and then inject them back into the patient at 3 months after transplantation. Patients will be closely monitored at King's College Hospital (expertese in hepatology and liver transplantation) with assessment of safety of the injected cells.The study's main focus is the assessment of safety of the cell based therapy and providing evidence which will support a larger study looking at the effectiveness of the therapy in the liver transplant recipients.
肝移植是治疗严重肝病患者的一种成功方法。尽管如此,大多数患者终身服用免疫抑制剂(抑制免疫系统的药物),并伴有相关的副作用,影响患者的生活质量和长期结局。因此,本研究的目的是i。确定新的基于细胞的疗法在肝移植患者中是否安全且耐受良好,以及ii.如果移植后能尽早停用免疫抑制药物(一旦患者接受了这种新疗法)。这种疗法的总体目标是允许接受肝移植的患者停用免疫抑制剂,最终目标是终身完全停用免疫抑制剂。有趣的是,受体中的免疫细胞群,称为调节性T细胞,已被证明可以调节患者的免疫系统并防止器官排斥。我们的研究旨在开发新的治疗方法,包括增加受体中这些细胞的数量。我们将A。在移植时从受体分离这些细胞,在数量上扩增它们并确保它们在培养中稳定,然后在移植后3个月将它们注射回患者体内。患者将在国王学院医院(肝脏病学和肝移植专家)密切监测,评估注射细胞的安全性。该研究的主要重点是评估基于细胞的治疗的安全性,并提供证据,这将支持一项更大的研究,研究肝移植受者的治疗效果。
项目成果
期刊论文数量(10)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
CD161 expression characterizes a subpopulation of human regulatory T cells that produces IL-17 in a STAT3-dependent manner.
- DOI:10.1002/eji.201243296
- 发表时间:2013-08
- 期刊:
- 影响因子:5.4
- 作者:Afzali, Behdad;Mitchell, Peter J.;Edozie, Francis C.;Povoleri, Giovanni A. M.;Dowson, Sophie E.;Demandt, Laura;Walter, Gina;Canavan, James B.;Scotta, Cristiano;Menon, Bina;Chana, Prabhjoat S.;Khamri, Wafa;Kordasti, Shahram Y.;Heck, Susanne;Grimbacher, Bodo;Tree, Timothy;Cope, Andrew P.;Taams, Leonie S.;Lechler, Robert I.;John, Susan;Lombardi, Giovanna
- 通讯作者:Lombardi, Giovanna
Feasibility, long-term safety, and immune monitoring of regulatory T cell therapy in living donor kidney transplant recipients.
- DOI:10.1111/ajt.16395
- 发表时间:2021-04
- 期刊:
- 影响因子:0
- 作者:Harden PN;Game DS;Sawitzki B;Van der Net JB;Hester J;Bushell A;Issa F;Brook MO;Alzhrani A;Schlickeiser S;Scotta C;Petchey W;Streitz M;Blancho G;Tang Q;Markmann J;Lechler RI;Roberts ISD;Friend PJ;Hilton R;Geissler EK;Wood KJ;Lombardi G
- 通讯作者:Lombardi G
Developing in vitro expanded CD45RA+ regulatory T cells as an adoptive cell therapy for Crohn's disease.
- DOI:10.1136/gutjnl-2014-306919
- 发表时间:2016-04
- 期刊:
- 影响因子:24.5
- 作者:Canavan JB;Scottà C;Vossenkämper A;Goldberg R;Elder MJ;Shoval I;Marks E;Stolarczyk E;Lo JW;Powell N;Fazekasova H;Irving PM;Sanderson JD;Howard JK;Yagel S;Afzali B;MacDonald TT;Hernandez-Fuentes MP;Shpigel NY;Lombardi G;Lord GM
- 通讯作者:Lord GM
A Rapamycin-Based GMP-Compatible Process for the Isolation and Expansion of Regulatory T Cells for Clinical Trials.
- DOI:10.1016/j.omtm.2018.01.006
- 发表时间:2018-03-16
- 期刊:
- 影响因子:0
- 作者:Fraser H;Safinia N;Grageda N;Thirkell S;Lowe K;Fry LJ;Scottá C;Hope A;Fisher C;Hilton R;Game D;Harden P;Bushell A;Wood K;Lechler RI;Lombardi G
- 通讯作者:Lombardi G
Spatiotemporal in vivo tracking of polyclonal human regulatory T cells (Tregs) reveals a role for innate immune cells in Treg transplant recruitment.
- DOI:10.1016/j.omtm.2020.12.003
- 发表时间:2021-03-12
- 期刊:
- 影响因子:0
- 作者:Jacob J;Nadkarni S;Volpe A;Peng Q;Tung SL;Hannen RF;Mohseni YR;Scotta C;Marelli-Berg FM;Lechler RI;Smyth LA;Fruhwirth GO;Lombardi G
- 通讯作者:Lombardi G
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Giovanna Lombardi其他文献
Regulatory T cell therapy is associated with distinct immune regulatory lymphocytic infiltrates in kidney transplants
调节性T细胞疗法与肾移植中独特的免疫调节性淋巴细胞浸润相关。
- DOI:
10.1016/j.medj.2024.11.014 - 发表时间:
2025-05-09 - 期刊:
- 影响因子:11.800
- 作者:
Oliver McCallion;Amy R. Cross;Matthew O. Brook;Conor Hennessy;Ricardo Ferreira;Dominik Trzupek;William R. Mulley;Sandeep Kumar;Maria Soares;Ian S. Roberts;Peter J. Friend;Giovanna Lombardi;Kathryn J. Wood;Paul N. Harden;Joanna Hester;Fadi Issa - 通讯作者:
Fadi Issa
Recipients With Chronic Rejection Significant Frequencies of T Cells With Indirect Anti-Donor Specificity in Heart Graft
慢性排斥的受者心脏移植物中具有间接抗供体特异性的 T 细胞的显着频率
- DOI:
- 发表时间:
2000 - 期刊:
- 影响因子:0
- 作者:
Richard Batchelor;Robert I. Lechler;Frasca;Giovanna Lombardi;Kenneth M. Taylor;Ling Weng;Marlene L. Rose;Magdi H. Yacoub;Philip Hornick;Philip D. Mason;Richard Baker;M. Hernandez;Loredana - 通讯作者:
Loredana
196. Genetic Manipulation of Dendritic Cells through the Use of Immunolipoplexes To Induce T Cell-Specific Tolerance In Vivo
- DOI:
10.1016/j.ymthe.2006.08.220 - 发表时间:
2006-01-01 - 期刊:
- 影响因子:
- 作者:
Peng H. Tan;Robert I. Lechler;Giovanna Lombardi;Andrew J.T. George - 通讯作者:
Andrew J.T. George
Conferring alloantigen specificity to regulatory T cells: A comparative analysis of cell preparations undergoing clinical development in transplantation
赋予调节性T细胞同种异体抗原特异性:对移植中正在进行临床开发的细胞制剂的比较分析
- DOI:
10.1016/j.ajt.2024.09.009 - 发表时间:
2025-01-01 - 期刊:
- 影响因子:8.200
- 作者:
Ada Sera Kurt;Paula Ruiz;Emmanuelle Landmann;Marwa Elgosbi;Tsz Kan Fung;Elisavet Kodela;Maria-Carlota Londoño;Diana Marin Correa;Elena Perpiñán;Giovanna Lombardi;Niloufar Safinia;Marc Martinez-Llordella;Alberto Sanchez-Fueyo - 通讯作者:
Alberto Sanchez-Fueyo
C-25: Evaluation of closed system medical device for low volume storage for clinical studies involving regulatory T cells
- DOI:
10.1016/j.cryobiol.2014.09.312 - 发表时间:
2014-12-01 - 期刊:
- 影响因子:
- 作者:
Evonne R. Fearnot;Henrieta Fazekasova;Sarah Thirkell;Katie Lowe;Andrew Bushell;Giovanna Lombardi - 通讯作者:
Giovanna Lombardi
Giovanna Lombardi的其他文献
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{{ truncateString('Giovanna Lombardi', 18)}}的其他基金
Immunogenicity test platform - in vitro and in vivo
免疫原性测试平台 - 体外和体内
- 批准号:
MR/S020934/1 - 财政年份:2019
- 资助金额:
$ 260.28万 - 项目类别:
Research Grant
Preclinical in vivo assessment of a combination of protein and cell therapies to prevent human islet transplant rejection as a cure for Type 1 diabete
蛋白质和细胞疗法组合预防人类胰岛移植排斥反应作为 1 型糖尿病治疗方法的临床前体内评估
- 批准号:
MR/K013165/1 - 财政年份:2013
- 资助金额:
$ 260.28万 - 项目类别:
Research Grant
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