NCT01624077

Safety Study of Using Regulatory T Cells Induce Liver Transplantation Tolerance

Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Promote Donor-specific Clinical Liver Transplantation Tolerance in Nanjing

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The first trial will involve the generation of donor alloantigen-specific CD4+CD25+ Tregs from peripheral blood of pre-transplant patients, the administration of the CD4+CD25+ Tregs (1 x 106 cells/kg) at several intervals (for graft specific tolerance induction).

Detailed description

The first trial will involve the generation of CD4+CD25+CD127- Tregs from peripheral blood of pre-transplant patients, followed by a course (up to 24 months) of tacrolimus (5-10 ng/ml) treatment (to prevent chronic rejection) and the administration of the CD4+CD25+CD127- Tregs (1 x 106 cells/kg) at several intervals (for tolerance induction). The immunesuppress drugs will be gradully withdraw within one year. The number of CD4+CD25+ Tregs needed is based on the assumption that the frequencies of alloreactive CD4+ T cells with direct and indirect allospecificity were 1/104 and 1/105, respectively. The second trial will be carried out in 1-10 year post living donor liver transplantation patients currently under immunosuppressive drug treatment. The investigators will isolate CD4+CD25+CD127- Tregs from these patients, and expand them with mismatched living donor antigens. The patients will be subsequently treated with the expanded donor-antigen specific CD4+CD25+CD127- Tregs (1 x 106 cells/kg) at several intervals, and immunosuppressive drug treatment will be withdrawn. In both clinical trials, the investigators will monitor the number of allospecific Tregs in patients at different time periods, and to test their suppressive functions in vitro. If there will be any signs of graft rejection, patients will be switched back to immunosuppressive drug treatment. The investigators expect that the innovative Tregs immunosuppressive regimen will lead to achieve permanent liver transplantation tolerance without the use of conventional immunosuppressive drugs: the holygrail in clinical transplantation medicine.

Conditions

• Chronic Rejection of Liver Transplant

Interventions

Type	Name	Description
BIOLOGICAL	Regulatory T cells	Tregs will inject after liver transplantation

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-06-20
• Last updated: 2015-02-24

Locations

1 site across 1 country: China