Autoimmune Diseases
Conditions
Keywords
Autoimmune Diseases, Treg
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALRegulatory T cells
Regulatory t cells will be injected back to autoimmune hepatitis patients
Sponsors
Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 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
1. Hepatocellular carcinoma or other Malignancies 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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Incidence of 2 times increase of immunology related level(serum levels of T cell subsets,immune globulin) or present other side effects. | 12 months |
Contacts
Primary ContactLing Lu, M.D.,PH.D.
Outcome results
None listed