Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis

Phase 1/2 Unknown 30 enrolled Nanjing Medical University

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2016-04
Primary completion: 2018-03
Completion: 2018-10

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Regulatory T cells	Cell therapy	5e+06 cells/kg	Other
Subject	Regulatory T cells	Cell therapy	1e+07 cells/kg	Other
Subject	Regulatory T cells	Cell therapy	2e+07 cells/kg	Other

Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis

Summary

Timeline

Publications

Drugs

Indications