Clinical Trial

CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This early-phase clinical trial will assess the use of ex vivo CRISPR-Cas9 genome editing on donor liver grafts to reduce immunogenicity before transplantation. Donor livers will have HLA-A and HLA-B genes knocked out, and HLA class II expression disabled (by targeting the CIITA transactivator gene), aiming to create a "hypoimmunogenic" organ less prone to rejection. The edited liver is then transplanted into patients with end-stage liver disease. The primary focus is on safety and feasibility - determining whether a CRISPR-edited liver can be transplanted successfully and function normally - as well as evaluating reductions in immune response (acute rejection, anti-donor T cell activation) and graft function over time.
Trial Details
NCT Number NCT07053488
Lead Sponsor AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC
Conditions Liver Diseases, Liver Cancer, Liver Cirrhosis, Liver Failure, Liver Metastases, Liver Transplant Rejection, Liver Steatoses
Enrollment 90 participants
Start Date 2025-06-01
Primary Completion 2027-12-18 (estimated)
Study Completion 2028-12-28 (estimated)
Updated on ClinicalTrials.gov 2025-07-08