Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000015789
• Date of registration: 29/11/2015
• Prospective Registration: No
• Primary sponsor: Traslational Research and Clinical Trial Center
• Public title: Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation
• Scientific title: Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation - Operational tolerance by a Treg therapy in LDLT
• Date of first enrolment: 2012/11/30
• Target sample size: 10
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018372
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase I,II

Countries of recruitment

Japan

Contacts

• Name: Kenichirou Yamashita
• Affiliation: Hokkaidou Graduate School of Medicine Department of Organ Transplantation

• Name: Satoru Todo
• Affiliation: Hokkaidou Universitu Graduate School of Medicine Professor Emeritus

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1.Recipient; 1).extrahepatic malignancy, 2). extrahepatic infection or sepsis, 3)pregnant woman, 4).sever cardio-pulmonary disease, 5). patients who are regarded as inadequate for the study by investigators 2.Donor; 1). Those with with abnormality or inadequacy in the liver as a. functional (fatty liver, autoimmune liver disease, et al), b. morhological (anomaly of hepatic artery, kepatic vein, portal vein or biliary tract), c.too small graft or remnant liver for transplantation, 2). with malignanct or infection, 3). with scychological inadequacy 4). beyond 6 degree relatives

Age minimum: 18years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

non-compenzated liver cirrhosis(HBV,HCV, alcoholic, etc), primary biliary cirrhosis (PBC), primary screlosing cholangitis (PSC), hepatocellular carcinoma (HCC within Milan criteria), non-alcoholic steatohepatitis (NASH), others

Intervention(s)

The patient is given cyclophosphamide (40mg/kg,iv) on postoperative days (POD) 5, and ex-vivo generated regulatory T cells on POD 13. Postoperative immunosuppression is with comventioal method. Tke immunosuppressant is reduced to 3/4 daily dose of the twice daily dose at 6 months, which is reduced to 3 times/week, 2 times/ week and 1 time/week every 3 months after confirming normal graft function and liver biopsy. the immunosuppressant is completely discontinued by 18 months after transplantation.

Primary Outcome(s)

1.Safety Immediate systemic changes (blood pressure, pulse, respiration, fever, et al), and intermediate and long-term effect on infection, de-novo malignancy, immune diseases, et al. 2.Efficacy: Liver function (ALT/AST/T-Bil/g-GTP, et al) and pathological changes (rejection/cell infiltrate/biliary changes/vascular damages, etal) of protocol-liver biopsies.

Source(s) of Monetary Support

Japanese Ministry of Health, Welfare and Labour (No.22130701)

Ethics review

Status: YES
Approval date:
Contact: