The goal of this clinical trial is to learn whether liver parenchyma chimerism can represent a chievement of operational tolerance in liver transplantation recipients. The researchers will examine the degree of parenchyma chimerism. The participants will withdraw or minimize their immunosuppression to avoid the adverse effects of immunosuppressants.
After liver transplantation, immunosuppression should be induced or maintained to prevent acute cell-mediated rejection or chronic antibody-mediated rejection.All these immunosuppressive agents have various adverse effects including nephrotoxicity, neurotoxicity, hyperglycemia, hypertension, bone marrow suppression, gastrointestinal disturbance, etc. We examine the liver specimen from long-term liver transplant recipients with stable liver function. The liver showed chimeric change of the liver. Therefore, the hypothesis of this study is that immunosuppressive agents can be withdrawn if the liver becomes chimeric. The specific aims of this study are: 1. To determine whether the liver allografts become chimeric in long-term liver transplant recipients. 2. To determine the degree of liver chimerism in long-term liver transplant recipients. 3. To determine whether immunosuppression can be withdrawn based on liver chimerism. Based on the degree of chimeric change of the liver grafts, immunosuppression withdrawal can be conducted in this study and find out the indicator of immunosuppression withdrawal in liver transplantation setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
Liver tissue will be obtained to perform short tandem repeat (STR) analysis to determine the degree of parenchymal chimerism.
For patients with an STR $\\ge$ 75% percentile cutoff, half dose of the immunosuppressive regimen is decreased for the first two months. If liver function is unaltered, immunosuppression is totally withdrawn at the 3rd month.
For patients with STR \> 15% but not reaching the 75% percentile cutoff, the immunosuppressive regimen is decreased by 1/3 at the first two months. If liver function is unaltered, it is further decreased to 1/2 of the original dose.
Chang-Gung Memorial Hospital
Taoyuan, Taiwan
Percentage of Recipient Cells in the Liver Allograft
Short tandem repeat (STR) analysis is used to calculate the chimeric percentage of recipient cells in the liver parenchyma.
Time frame: 1 year
Number of Participants with Successful Complete Immunosuppression Withdrawal
The number of enrolled patients who successfully complete the immunosuppression withdrawal protocol and remain immunosuppression-free without experiencing acute cell-mediated rejection.
Time frame: up to 1 year
AST Levels
Aspartate aminotransferase (AST) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.
Time frame: up to 1 year
ALT Levels
Alanine aminotransferase (ALT) levels will be monitored to evaluate liver allograft stability and function after immunosuppression withdrawal or minimization.
Time frame: up to 1 year
eGFR (Estimated Glomerular Filtration Rate)
eGFR will be measured to evaluate the improvement of immunosuppressant-related renal adverse effects following drug withdrawal or minimization.
Time frame: At 3 months after immunosuppression withdrawal
HbA1c (Glycated Hemoglobin)
HbA1c will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.
Time frame: At 3 months after immunosuppression withdrawal
Cholesterol Profiles
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Cholesterol profiles will be measured to evaluate the improvement of immunosuppressant-related metabolic adverse effects following drug withdrawal or minimization.
Time frame: At 3 months after immunosuppression withdrawal