Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis
NCT ID: NCT02704338
Last Updated: 2016-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2016-04-30
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Regulatory T cells
Regulatory t cells will be injected back to autoimmune hepatitis patients
Interventions
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Regulatory T cells
Regulatory t cells will be injected back to autoimmune hepatitis patients
Eligibility Criteria
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Inclusion Criteria
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
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.
10 Years
70 Years
ALL
No
Sponsors
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Nanjing Medical University
OTHER
Responsible Party
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Ling Lu
Principal Investigator
Principal Investigators
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Hong Wang, M.D.,PH.D.
Role: STUDY_CHAIR
Nanjing Medical University
Central Contacts
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References
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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.
Other Identifiers
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NJLT002
Identifier Type: -
Identifier Source: org_study_id
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