Status and phase
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About
The purpose of this clinical trial is to examine the immunotolerance-inducing ability (effectiveness) of induced inhibitory T cells JB-101 in patients with living-donor liver transplantation using "whether or not operational tolerance is achieved" as an index.
And the safety of JB-101 will be evaluated.
Full description
This trial is a phase I / II, open-label, single-arm, multicenter clinical trial of JB-101, an inducible inhibitory T cell, in patients with end-stage liver failure who undergo living-donor liver transplantation.
The primary endpoint of efficacy is withdrawal from immunosuppressant by 78 weeks (up to 91 weeks) after liver transplantation, and then "whether or not operational tolerance is achieved".
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria：
Patients with end-stage liver failure undergoing living-donor liver transplantation.
Subjects who are healthy physically and psychologically and willing to donate organs voluntarily.
Relative within the second degree of relationship or partner. (Acceptable degree conforms eligibility criteria of the institution.)
Exclusion Criteria：
Patients who have clinical findings of active infection.
Patients with advanced heart disease, fulminant hepatitis in liver failure, renal disease, malignant tumors and complications of immunodeficiency.
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Central trial contact
Saori Hirota; Tatsunori Toyonaga
Data sourced from clinicaltrials.gov
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