NCT02166177

Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients

Pilot Study Evaluating the Safety and Efficacy Profile of Regulatory T Cell Therapy in Liver Transplant Recipients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation

Detailed description

Stage I: To evaluate the safety of administering TR002 to liver transplant recipients. Stage II: To evaluate the efficacy of TR002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.

Conditions

• End-stage Liver Disease

Interventions

Type	Name	Description
DRUG	Autologous regulatory T cell product	Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus.

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-01-22
• Completion: 2018-01-22
• First posted: 2014-06-18
• Last updated: 2019-01-10

Locations

1 site across 1 country: United Kingdom