Phase I/II Study to Evaluate the Safety and Efficacy of JB-101(Induced T Cell With Suppressing Functions), to Induce Operational Tolerance in Living Donor Liver Transplantation. - Induction of Transplant Tolerance in LDLT Via iTS

chida Koichiro0 sites10 target enrollmentDecember 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

December 17, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

chida Koichiro

•(1\) Recipient
•1\) Patients who have given written informed consent to participate in the clinical trial.
•2\) Male or Female patients aged between 20 and 80 years old at the time of obtaining informed consent.
•3\) Patients who have been approved or will be approved for living\-donor liver transplantation at the Medical Ethics Committee or equivalent organization established by the institution.
•1\) Patients who are healthy physically and psychologically and willing to donate organs voluntarily.
•2\) Patients who have given written informed consent to participate in the clinical trial.
•3\) Relative within the second degree of relationship or partner. (Acceptable degree conforms eligibility criteria of the institution.)
•4\) Male or Female patients aged between 20 and 65 years old at the time of obtaining informed consent.
•5\) Patients who match or adapt to recipients blood type.
•6\) Patients who have been approved or will be approved for living\-donor liver transplantation at the Medical Ethics Committee or equivalent organization established by the institution.

•(1\) Recipient
•1\) Patients who have clinical findings of active infection at the time of screening.
•2\) Patients who meet the following criteria at the time of screening.
•SBP 90 or \>\=180 mmHg
•DBP \<50 or \>\= 100 mmHg
•3\) Patients who have following complications at the time of screening. (Previous medical history is acceptable.)
•\- Severe cardiac disease; Heart failure, Myocardial infarction, Myocarditis
•\- The hepatitis fulminant of the hepatic failure state.
•\- Renal disease; Nephrotic syndrome, Renal failure (acute and chronic), Uremia, Hydronephrosis
•\- Malignant neoplasm(Hepatocellular carcinoma is acceptable.)