ThRIL;A 'first-in-human' study, evaluating the safety, tolerability with an investigation into the efficacy of Tregs in liver transplant recipients

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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 if immunosuppressive drugs can be withdrawn early after transplantation (once the patient has had this new therapy).The general aim of this therapy is to allow the withdrawal of immunosuppressants in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.