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
About this trial
This is an interventional treatment trial for Autoimmune Diseases focused on measuring Autoimmune Diseases, Treg
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.
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
NCT ID
NCT02704338
First Posted
February 28, 2016
Last Updated
March 4, 2016
Sponsor
Nanjing Medical University
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
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Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis
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