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

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Completed; Phase 2; Phase 1

Conditions: End-stage Liver Disease

Treatments: Drug: Autologous regulatory T cell product

Study type: Interventional

Funder types: Other

Identifiers

NCT02166177

Treg Liver Trial

Details and patient eligibility

About

'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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Autologous Regulatory T cell therapy

Experimental group

Description:

Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)

Treatment:

Drug: Autologous regulatory T cell product