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Immune Tolerance Induction After Liver Transplantation

NCT07269041 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-12

No results posted yet for this study

Summary

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."

Conditions

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

Interventions

BIOLOGICAL

Donor Hematopoietic Stem and Progenitor Cell Infusion

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.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Veale, MD · UCLA Health

  • Cray V. Noah, MD · UCLA Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2029-01-31
Completion
2033-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269041 on ClinicalTrials.gov