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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-01-22

Brief Summary

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'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

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Detailed Description

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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

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End-stage Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Regulatory T cell therapy

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

Group Type EXPERIMENTAL

Autologous regulatory T cell product

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No