Actively Recruiting
CRISPR-Edited HLA Donor Kidney Transplant to Reduce Rejection Risk
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 clinical trial investigates the transplantation of donor kidneys that have been genetically modified ex vivo using CRISPR-Cas9 genome editing to reduce immunogenicity and transplant rejection. Donor kidney grafts will have key human leukocyte antigen (HLA) genes disrupted - specifically, knockout of HLA class I heavy chains HLA-A and HLA-B, along with disabling HLA class II expression by targeting the CIITA gene (a master regulator of HLA-DR/DQ/DP). Approximately 90 adult end-stage renal disease patients will receive a CRISPR-edited donor kidney transplant. The primary objectives are to assess the safety and feasibility of this novel intervention, while secondary objectives evaluate the reduction in immune responses (immunogenicity), graft function, and the practicality of implementing ex vivo gene-edited organ transplantation in humans. By knocking out major donor HLA molecules, the trial aims to reduce T-cell and antibody-mediated recognition of the graft, potentially lowering rejection rates and reliance on high-dose immunosuppressants. Safety, including any off-target effects or unanticipated immune reactions, will be closely monitored, and transplant outcomes will be tracked for one year post-transplant.
CONDITIONS
Official Title
CRISPR-Edited HLA Donor Kidney Transplant to Reduce Rejection Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 16 to 85 years with end-stage renal disease who are candidates for kidney transplant
- Eligible for transplant surgery with no contraindications
- Suitable deceased-donor kidney available that is ABO compatible
- Able to provide informed consent and comply with study procedures
- Negative T and B cell crossmatch with donor organ prior to transplant
- Women of childbearing potential have negative pregnancy test and use contraception; men with partners of childbearing potential use contraception
- Patients with high immunologic risk (high panel reactive antibody levels) are eligible
- Able to attend long-term follow-up visits at the study center in China or travel as needed
You will not qualify if you...
- Active severe infection contraindicating transplantation or immunosuppression
- Pregnant or breastfeeding women
- Need for multi-organ transplant simultaneously
- Severe uncontrolled co-morbidities increasing transplant risk
- Contraindications to immunosuppressive therapy
- Inability to follow protocol due to psychiatric, cognitive, or social reasons
- Previous participation in investigational gene therapy or experimental transplant treatments
- Clinically significant laboratory abnormalities increasing risk
- Donor kidney unsuitable for gene editing or transplant
AI-Screening
AI-Powered Screening
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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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