Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
Xeno Holdings (US), LLC dba ChoironeX
Summary
The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months * Eligible for kidney transplantation per site criteria * \<50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months * Blood type and immunologic compatibility with study transplant confirmed by testing * EBV seropositive * Up to date on recommended vaccinations for immunocompromised individuals * Willing to use protocol-required contraception * Able to provide informed consent and comply with lifelong follow-up Exclusion Criteria: * Requirement for multi-organ transplantati…
Interventions
- BiologicalChoironeX GalKO Porcine Thymokidney
A constructed thymokidney from a genetically modified porcine donor will be preserved, packaged, transported and transplanted into the study subject at the study site in the same fashion as a human donor kidney. The thymokidney will remain in the subject throughout the subject's lifetime, or until thymokidney explant.
Locations (2)
- Study Site 2New York, New York
- Study Site 1New York, New York