Actively Recruiting
CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection
Led by AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC · Updated on 2025-07-08
90
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 16-85 (inclusive) with end-stage liver disease or acute liver failure eligible for liver transplantation
- Require a liver transplant and have been assigned a donor liver graft from a deceased donor to be used after gene editing
- No immediately available fully HLA-matched donor
- Medically suitable for transplant surgery and able to tolerate standard immunosuppressive therapy
- Able to understand the investigational nature and provide written informed consent
- Willing to comply with study procedures and available for follow-up including frequent visits
You will not qualify if you...
- Active uncontrolled infection such as sepsis or active tuberculosis
- Uncontrolled HIV or poorly managed chronic viral infections
- Need for multi-organ transplant beyond liver alone
- Pregnancy or breastfeeding without effective contraception
- Severe illness limiting survival to less than 1 year or making transplant unsuitable
- Known severe allergy to study-related products such as CRISPR components
- Inability to follow the study protocol or comply with follow-up due to psychiatric, social, or logistical reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Health Science Center (PKUHSC)
Beijing, Changping, China, 102206
Actively Recruiting
Research Team
A
Andrew R Linehan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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