About this trial
This clinical trial is being conducted to help liver transplant recipients safely discontinue toxic immunosuppressive drugs years after surgery. Lifelong use of these drugs is the current standard, but they come with life-threatening side effects. UCLA has pioneered this "Delayed Tolerance" approach, achieving success in numerous kidney recipients now living drug-free. The process uses a conditioning regimen followed by donor stem cell infusion to retrain the immune system to accept the liver as "self."
Eligibility criteria
Qualifiers
Males and females ages 18 years and older with a pre-existing liver transplant from a living donor with a donor-recipient match at 6 or more out of 12 alleles across the HLA-A, -B, -C, -DR, -DQ, and -DP loci, as determined by high-resolution HLA typing.
Pre-existing living-donor liver transplant must be 12 months to 20 years from date of scheduled HSPC infusion.
Agreement to participate in the study and ability to give informed consent.
Liver biopsy within 4 weeks of enrollment without signs of rejection.
Disqualifiers
Major ABO incompatibility with donor.
Any of the following labs > 2.0 times the upper limit of normal on screening: AST, ALT, ALP, GGT or TBil.
History of rejection with current HLA-matched liver transplant within the last year.
History of GVHD following liver transplant.
Trial design
Treatments tested in this trial
- Donor Hematopoietic Stem and Progenitor Cell Infusion