Induction of Transplant Tolerance in LDLT Via iTS

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    10
  • sponsor
    Juntendo University
Updated on 24 September 2021

Summary

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.

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".

Details
Condition Living Donor Liver Transplantation
Treatment JB-101
Clinical Study IdentifierNCT04950842
SponsorJuntendo University
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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