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

Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation - Operational tolerance by a Treg therapy in LDLT

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015789

Enrollment

Registered

2015-11-29

Start date

2012-11-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 im

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A case who is approved by the Tranplantation Evaluation Committee and the IRB at Hokkaidou University 2.Recipient; 1). paitent suffering from end-stage liver disease that is indicated for liver transplantation for cure, 2). Patient who understands the protocol with a written informed concent 3. Donor; 1).Within 6 degree relatives 2).Donor who understands the protocol with a written informed concent, 3). 18 years old and more

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactKenichirou Yamashita

Hokkaidou Graduate School of Medicine Department of Organ Transplantation

kenchan@med.hokudai.ac.jp011-706-7062

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026