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

'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

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.

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.