Immune Tolerance Induction After Liver Transplantation

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT07269041
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Chimerism
  • End Stage Liver Disease
  • Graft Survival
  • Hematopoietic Stem Cell
  • Immune Tolerance
  • Immune Tolerance/Drug Effects
  • Immunosuppression After Liver Transplantation
  • Immunosuppression Disorders
  • Liver Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Donor Hematopoietic Stem and Progenitor Cell Infusion — BIOLOGICAL
    Participants with a pre-existing, well-functioning HLA-matched living-donor liver transplant from the same donor will receive a delayed infusion of donor-derived hematopoietic stem and progenitor cells (HSPCs). Donors undergo mobilization and apheresis to collect peripheral blood stem cells, which are processed to generate a CD34+ cell product with an accompanying defined CD3+ T-cell dose. Recipients receive outpatient conditioning with total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG) prior to infusion. The goal of the intervention is to induce tolerance by achieving durable mixed chimerism and enable structured withdrawal of maintenance immunosuppression.

Study Details

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."

Key Dates

Start date
Feb 20, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2033

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tolerance Induction Arm
    Adult recipients with a pre-existing, well-functioning HLA-matched living-donor liver transplant from the same donor will undergo outpatient conditioning with total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG), followed by infusion of mobilized donor hematopoietic stem and progenitor cells (separate CD34+ and CD3+ fractions). After HSPC infusion, participants will be monitored for donor chimerism, graft function, rejection, and GVHD, and will undergo a structured taper of maintenance immunosuppression with the goal of complete withdrawal if donor chimerism is present and protocol criteria are met.

Primary Outcome Measure

Percentage of subjects weaned off liver transplant immunosuppressants at 12 months after HSPC infusion [ Time Frame: 12 months post-HSPC infusion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Health 200 Medical PlazaLos AngelesCalifornia90095
Cray V. Noah, MD
[email protected]
310-267-7727
Ruth Jones
[email protected]
424-402-9564
Jeffrey Veale, MD (PRINCIPAL_INVESTIGATOR)
Cray V. Noah, MD (SUB_INVESTIGATOR)
Caspian Oliai, MD (SUB_INVESTIGATOR)
Ann Raldow, MD (SUB_INVESTIGATOR)
Jasleen Singh, MD (SUB_INVESTIGATOR)
Samer Ebaid, MD, PhD, MS (SUB_INVESTIGATOR)

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By research site
UCLA Health 200 Medical Plaza· Los Angeles, CA

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