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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regulatory T cells | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regulatory T cells | Biological | Regulatory t cells will be injected back to autoimmune hepatitis patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical remission(serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin within normal ranges) | 12 months | |
| immunology remission(=serum levels of T cell subsets, immune globulin, and complement within normal ranges) and lack of other side effects. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biochemical remission 2 times increase of serum levels of alanine aminotransferase, aspartate aminotransferase and Total bilirubin. | 12 months | |
| Suspected rejection detected by clinical feature or biopsy. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Lu, M.D.,PH.D. | Contact | 86-25-68136053 | lvling@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Wang, M.D.,PH.D. | Nanjing Medical University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35179437 | Derived | 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. |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Incidence of 2 times increase of immunology related level(serum levels of T cell subsets,immune globulin) or present other side effects. | 12 months |