Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis (Treg)

March 4, 2016 updated by: Ling Lu, Nanjing Medical University

Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in Autoimmune Hepatitis

Separated and expanded the CD4+CD25+CD127- Tregs from peripheral blood of autoimmune hepatitis patients and administrate the cells (5 x 106 cells/kg) into patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The trial will be carried out in autoimmune patients. The investigators will isolate CD4(cluster of differentiation)+CD25(cluster of differentiation25)+CD127(cluster of differentiation127)- Tregs from these patients, and expand them with IL(interleukin)-2 retinoid acid and anti-CD3(cluster of differentiation 3) /CD28(cluster of differentiation 28) beads. The patients will be subsequently treated with single infusion of CD4+CD25+CD127- Tregs (10-20 x 106 cells/kg).

In the clinical trials, the investigators will monitor the number of Tregs in patients at different periods, and to test their suppressive functions in vitro. Also the function and biopsy of liver will be processed to determine the efficacy of Treg therapy.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent
  2. Autoimmune hepatitis(according to the criteria defined by the international autoimmune hepatitis Group ,Hepatology, 2008;48:169-176)
  3. Negative pregnancy test
  4. Moderately active disease under standard treatment

Exclusion Criteria:

  1. Hepatocellular carcinoma or other Malignancies
  2. Pregnant or lactating women
  3. Vital organs failure (Cardiac, Renal or Respiratory, et al)
  4. Sepsis
  5. Active thrombosis in the portal or hepatic veins
  6. Concomitant psychiatric disease or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give informed consent
  7. Surgery during the last 2 months or surgery planned during the study,
  8. Participation in other biomedical research in the last 3 months or planned during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Regulatory T cells
CD4(cluster of differentiation)+CD25+CD127- T cells isolated from peripheral blood mononuclear cells were be expanded with GMP(Good Manufacturing Practice) anti-CD3/CD28 coated beads in the presence of IL-2 and all-trans retinoid acid.
Biological: Regulatory T cells
Regulatory t cells will be injected back to autoimmune hepatitis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemical remission(serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin within normal ranges)
Time Frame: 12 months
12 months
immunology remission(=serum levels of T cell subsets, immune globulin, and complement within normal ranges) and lack of other side effects.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of biochemical remission 2 times increase of serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin.
Time Frame: 12 months
12 months
Suspected rejection detected by clinical feature or biopsy.
Time Frame: 12 months
12 months
Incidence of 2 times increase of immunology related level(serum levels of T cell subsets,immune globulin) or present other side effects.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Investigators

  • Study Chair: Hong Wang, M.D.,PH.D., Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

February 28, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (ESTIMATE)

March 10, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJLT002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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