CRISPR-Edited HLA Donor Kidney Transplant to Reduce Rejection Risk

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 a

Trial Details

NCT ID
NCT07053462
Phase
PHASE1 / PHASE2
Sponsor
AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Ex Vivo CRISPR-Cas9 Gene Editing of Donor Kidney
  • Kidney Transplantation with Standard Care
Locations (sample)
  • Beijing, Changping, China|39.9075,116.39723

Key Eligibility Criteria

  • Adult patients, age 16 to 85 years, with end-stage renal disease (ESRD) who are candidates for kidney transplantation. This includes patients on di…
  • Eligible for transplant surgery based on medical assessment (i.e., no contraindications to major surgery and transplantation). The patient's overal…
  • Suitable donor organ available: A deceased-donor kidney that meets standard acceptable criteria for transplant (e.g., adequate organ function and a…
  • Informed consent: The patient (or legally authorized representative) is able to understand the experimental nature of the study and has voluntarily…

For full eligibility, visit ClinicalTrials.gov.

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