Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis (Treg)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Diseases||Biological: Regulatory T cells||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Biochemical remission(serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin within normal ranges) [ Time Frame: 12 months ]
- 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 ]
- Incidence of biochemical remission 2 times increase of serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin. [ Time Frame: 12 months ]
- Suspected rejection detected by clinical feature or biopsy. [ Time Frame: 12 months ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT02704338
|Contact: Ling Lu, M.D.,PH.D.||firstname.lastname@example.org|
|Study Chair:||Hong Wang, M.D.,PH.D.||Nanjing Medical University|