Tracking the biomarker of liver transplant graft acceptance or rejection during the induction and maintenance phase of tolerance via induced T cells with suppressing function.

JRCT ID: jRCT1030200339

Registered date:02/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Living Donor Liver Transplant
• Date of first enrollment: 14/01/2021
• Target sample size: 20
• Study type: Observational

Outcome(s)

Primary Outcome

1)Trends in the percentage change from baseline in the percentage of regulatory T cells in the peripheral blood at each assessment point after administration of inducible inhibitory T cells
2)Evolution of the expression distribution of tolerant system cells (regulatory T cells, immune synapses, and tolerant system dendritic cells) in the graft during the course of immune tolerance induction after liver transplantation from baseline to each assessment time point.
3)Changes in the expression of inflammatory/inhibitory molecules and cytokine genes of immune cells infiltrating grafts and grafts from baseline during the process of induction of immune tolerance after liver transplantation.
4)Trends in percent change from baseline in immune anti-donor responsiveness at each assessment time point during the process leading to immune tolerance.
5)Correlations between mitotic capacity and rejections of CD4T,CD8T cells.
6)Correlations between mitotic capacity and histocompatibility of CD4T,CD8T cells.
7)Correlations between mitotic potential of CD4T,CD8T cells and primary diseases.
8)Clinical event rates at 2 years, 3 years, 4 years, and 5 years of dose reduction 5
9) Calcineurin inhibitor withdrawal rates at 2, 3, 4, and 5-year assessment of dose reduction 5
10) Patient Survival at 2, 3, 4, and 5 Years Assessment of Weight Loss 5
11) Graft survival at 2 years, 3 years, 4 years, and 5 years of dose reduction 5

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Inclusion criteria for subjects (recipients)
1) Individuals participating in prior clinical studies or JB-101-01 trials
2) Men and women aged 20 years or older and younger than 80 years at the time of informed consent
3) Participants in JB-101-01 trial who received adequate explanation for participating in the study and then gave written informed consent to the patient's own free will.
Inclusion criteria for donors (liver donors)
1) Participants in JB-101-01 trials
2) Individuals who gave written informed consent to participate in this study after receiving adequate explanation.

Exclude criteria

exclusion criteria for subjects (recipients)
1) Individuals or proxies who have offered refusal to participate in prior clinical research participants
2) In addition, the study director, etc. judged it inappropriate to be the subject of this study for reasons such as difficulty in evaluating the endpoints throughout the study period.
exclusion criteria for donors (liver donors)
1) Individuals who are judged to be inappropriate for the purpose of this study by the research director etc. due to difficulties in evaluating the endpoints throughout the study period, etc.

Related Information

• Primary Sponsor: Uchida Koichiro
• Source(s) of Monetary Support: JUNTEN BIO