search
Back to results

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

Primary Purpose

Autoimmune Diseases

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Regulatory T cells
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring Autoimmune Diseases, Treg

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Regulatory T cells

    Arm 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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 28, 2016
    Last Updated
    March 4, 2016
    Sponsor
    Nanjing Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02704338
    Brief Title
    Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis
    Acronym
    Treg
    Official Title
    Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in Autoimmune Hepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autoimmune Diseases
    Keywords
    Autoimmune Diseases, Treg

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Regulatory T cells
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Biological
    Intervention Name(s)
    Regulatory T cells
    Intervention Description
    Regulatory t cells will be injected back to autoimmune hepatitis patients
    Primary Outcome Measure Information:
    Title
    Biochemical remission(serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin within normal ranges)
    Time Frame
    12 months
    Title
    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 Measure Information:
    Title
    Incidence of biochemical remission 2 times increase of serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin.
    Time Frame
    12 months
    Title
    Suspected rejection detected by clinical feature or biopsy.
    Time Frame
    12 months
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written informed consent Autoimmune hepatitis(according to the criteria defined by the international autoimmune hepatitis Group ,Hepatology, 2008;48:169-176) Negative pregnancy test Moderately active disease under standard treatment Exclusion Criteria: Hepatocellular carcinoma or other Malignancies Pregnant or lactating women Vital organs failure (Cardiac, Renal or Respiratory, et al) Sepsis Active thrombosis in the portal or hepatic veins 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 Surgery during the last 2 months or surgery planned during the study, Participation in other biomedical research in the last 3 months or planned during the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ling Lu, M.D.,PH.D.
    Phone
    86-25-68136053
    Email
    lvling@njmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hong Wang, M.D.,PH.D.
    Organizational Affiliation
    Nanjing Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35179437
    Citation
    Chung YY, Rahim MN, Heneghan MA. Autoimmune hepatitis and pregnancy: considerations for the clinician. Expert Rev Clin Immunol. 2022 Apr;18(4):325-333. doi: 10.1080/1744666X.2022.2044307. Epub 2022 Mar 2.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs