Ex Vivo Perfusion of Gene-Edited Porcine Livers in Patients With Severe Hepatic Failure

Summary

The goal of this clinical trial is to evaluate whether extracorporeal perfusion using a gene-edited pig liver can significantly improve liver function and serve as a bridge-to-transplant therapy in patients with severe hepatic failure. It will also assess the survival and functionality of the xenogeneic liver and monitor the safety of the procedure. The main questions it aims to answer are: * Can extracorporeal perfusion with a gene-edited pig liver significantly improve liver function indicators (including biochemical, coagulation, and metabolic parameters) in patients with severe hepatic failure? * Is the gene-edited pig liver viable and functional during extracorporeal perfusion, as evidenced by bile secretion, adequate blood flow, and acceptable histopathological findings? * What adverse events occur in participants during and after extracorporeal xenogeneic liver perfusion? This is a single-arm study without a comparison group. Participants will: * Undergo screening assessments to confirm eligibility for severe hepatic failure diagnosis * Receive extracorporeal perfusion with a gene-edited pig liver for up to 14 days (or until transplantation/clinical improvement) * Receive intensive immunosuppressive therapy including tacrolimus, rituximab, ATG, mycophenolate mofetil, and other medications to prevent rejection Undergo hourly vital sign monitoring and daily blood tests (liver function, renal function, coagulation, inflammatory markers) during the perfusion period * Have daily abdominal ultrasounds and liver biopsies every other day to assess graft function and rejection

Timeline

Start

2026-01-31

Primary completion

2026-02-03

Completion

2026-12-31

Drugs

Indications