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

Nanjing Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Autoimmune Diseases

Treatments: Biological: Regulatory T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02704338

NJLT002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Regulatory T cells

Experimental group

Description:

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.

Treatment:

Biological: Regulatory T cells