Autoimmune Diseases Clinical Trial
Official title:
Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in Autoimmune Hepatitis
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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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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