Pig liver keeps patient alive in World-First Bridge-to-Transplant trial
NCT ID NCT07519005
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether a gene-edited pig liver, used outside the body like a dialysis machine, can temporarily support liver function in one person with severe liver failure. The goal is to keep the patient stable until a human liver transplant becomes available. Participants receive strong anti-rejection drugs during the procedure, and the study closely monitors safety and liver function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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1 person
The number who actually took part.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Hepatobiliary Surgery, Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, 710032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.