Safety Study of Using Regulatory T Cells Induce Liver Transplantation Tolerance (Treg)
|ClinicalTrials.gov Identifier: NCT01624077|
Recruitment Status : Unknown
Verified December 2014 by Ling Lu, Nanjing Medical University.
Recruitment status was: Active, not recruiting
First Posted : June 20, 2012
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rejection of Liver Transplant||Biological: Regulatory T cells||Phase 1|
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specific CD4+CD25+CD127- Tregs (1 x 106 cells/kg) at several intervals, and immunosuppressive drug treatment will be withdrawn.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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Clinical Trial Using Regulatory T Cells as Individualized Medicine to Promote Donor-specific Clinical Liver Transplantation Tolerance in Nanjing|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Regulatory T cells
Naïve CD4+ T cells isolated from peripheral blood mononuclear cells were stimulated with GMP anti-CD3/CD28 coated beads in the presence of IL-2 ,TGF-β.
Biological: Regulatory T cells
Tregs will inject after liver transplantation
Other Name: Treg
- Patient and graft survival [ Time Frame: one year posttransplantation ]
- Patient and graft survival [ Time Frame: 3 years post transplantation ]
- Incidence rate of biopsy-proven acute or chronic organ rejection [ Time Frame: 3 years post transplantation ]
- Incidence of adverse events associated with liver transplantation and immunosuppression [ Time Frame: 3 years posttransplantation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624077
|Nanjing Medical University|
|Nanjing, Jiangsu, China, 210029|
|Study Chair:||Hong Wang, MD||The First Affiliated Hospital with Nanjing Medical University|