Yükleniyor... / Loading...
This study investigates connecting a six-gene-edited pig liver to the patient's blood circulation outside the body (ex vivo perfusion), together with multi-drug immunosuppressive therapy, in people with severe liver failure. Adults aged 18 to 70 diagnosed with severe hepatic failure who can tolerate the procedure may take part. It is in Early Phase 1 and is currently not recruiting but ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Age and Gender: Adults aged 18-70 years, any gender. * Diagnosis of Severe Hepatic Failure: Patients meeting diagnostic criteria from the "Guidelines for Diagnosis and Treatment of Hepatic Failure (2024 Edition)" including: Acute liver failure: Acute onset without underlying liver disease history, developing grade II or higher hepatic encephalopathy within 4 weeks Subacute liver failure: Acute onset without prior liver disease, clinical manifestations of liver failure appearing within 4-24 weeks Acute-on-chronic liver failure: Acute deterioration of liver function on the basis of chronic liver disease (with or without cirrhosis), presenting as liver and/or extrahepatic organ failure with high short-term mortality (28-day mortality ≥15%) Chronic liver failure: Progressive liver function decline on the basis of cirrhosis resulting in chronic hepatic decompensation (recurrent ascites and/or hepatic encephalopathy) All patients must have: Grade II or higher hepatic encephalopathy, confirmed by a third-party independent expert panel of three members assessing poor treatment response and extremely high short-term mortality risk. * Surgical Tolerance: Other organs besides the liver must be able to tolerate the trauma of extracorporeal liver perfusion surgery. * Informed Consent: Parents, spouses, and adult children (immediate family members) must be fully informed and voluntarily sign the informed consent form, with ability to complete the trial as required by the protocol. Exclusion Criteria: * Immune Dysfunction: Individuals with HIV infection, diagnosed systemic immune diseases, or those undergoing immunosuppressive therapy affecting systemic immune function. * Prior Transplantation: Previous recipients of allogeneic tissue or organ transplantation. * Religious/Ethnic Restrictions: Individuals who cannot accept swine-derived materials due to religious beliefs, ethnic considerations, or other reasons. * Recent Trial Participation: Participation in other clinical studies within 3 months prior to enrollment. * Surgical Contraindications: Pathological changes at the planned operative site rendering surgery inoperable, or presence of critical organ failure or systemic severe infections precluding surgical intervention. * Investigator Discretion: Patients deemed unsuitable for participation by the investigator for other reasons.