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

Phase 1

• Conditions: Autoimmune Diseases

• Registration Number: NCT02704338
• Lead Sponsor: Nanjing Medical University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-02-28
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-04
• Last Update Submitted: 2016-03-04
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Study Start: 2016-04
• Primary Completion: 2018-03
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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