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

• Status: Completed
• Trial end date: 2018-01-22
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborator: King's College London

Criteria

Inclusion Criteria:

• Able to give informed consent

• adult patients with end-stage liver disease listed for primary liver transplant;

• calculated MELD score ≤ 25 at time of transplantation

Exclusion Criteria:

• HIV or RNA-positive Hepatitis C Virus infection;

• autoimmune liver disease

• previous organ transplant

• Ebstein Virus and/or Cytomegalovirus sero-negativity

• chronic use of systemic immunosuppressants

• hepatocellular carcinoma outside Milano criteria

• leukocytes <1.5x10^9/L and/or platelets <50x10^9/L.