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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02704338
Recruitment Status : Unknown
Verified March 2016 by Ling Lu, Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Information provided by (Responsible Party):
Ling Lu, 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.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Biological: Regulatory T cells Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in Autoimmune Hepatitis
Study Start Date : April 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Biochemical remission(serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin within normal ranges) [ Time Frame: 12 months ]
  2. 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 ]

Secondary Outcome Measures :
  1. Incidence of biochemical remission 2 times increase of serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin. [ Time Frame: 12 months ]
  2. Suspected rejection detected by clinical feature or biopsy. [ Time Frame: 12 months ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02704338

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Contact: Ling Lu, M.D.,PH.D. 86-25-68136053

Sponsors and Collaborators
Nanjing Medical University
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Study Chair: Hong Wang, M.D.,PH.D. Nanjing Medical University
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Responsible Party: Ling Lu, Principal Investigator, Nanjing Medical University Identifier: NCT02704338    
Other Study ID Numbers: NJLT002
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Keywords provided by Ling Lu, Nanjing Medical University:
Autoimmune Diseases, Treg
Additional relevant MeSH terms:
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Hepatitis, Autoimmune
Autoimmune Diseases
Liver Diseases
Digestive System Diseases
Immune System Diseases
Hepatitis, Chronic