Trial · NCT07519005
Ex Vivo Perfusion of Gene-Edited Porcine Livers in Patients With Severe Hepatic Failure
NCT07519005, Early phase 1, Active not recruiting, Xijing Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ex Vivo Perfusion of Gene-Edited Porcine Livers in Patients With Severe Hepatic Failure. Trials, record NCT07519005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07519005
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ex Vivo Perfusion of Gene-Edited Porcine Livers in Patients With Severe Hepatic Failure
- NCT number
- NCT07519005
- Status
- Active not recruiting
- Phases
- Early phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- Xijing Hospital
- Conditions
- Hepatic Failure
- Interventions
- Ex vivo perfusion of six-gene-edited porcine liver, Multi-drug immunosuppressive therapy
- First posted
- 2026-04-09
- Last updated
- 2026-04-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in liver function parameters from baseline | From initiation of perfusion (Day 0) until discontinuation of perfusion, up to 14 days | Evaluation of changes in key liver function biomarkers including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), albumin (ALB), and international normalized ratio (INR) measured daily during extracorporeal perfusion. Success is defined as stabilization or improvement of these parameters compared to baseline, indicating the gene-edited porcine liver can effectively support metabolic functions and serve as a bridge-to-transplant therapy. |
| Secondary | Viability and functional capacity of the ex vivo perfused porcine liver | Daily from Day 0 until graft removal or participant discontinuation, up to 14 days | Assessment of xenograft function through: Bile secretion: Volume and color of bile produced daily Vascular patency: Blood flow in portal vein, hepatic artery, and hepatic veins assessed by daily Doppler ultrasound Histopathological evaluation: Liver biopsy performed every other day to assess preservation injury and rejection reactions (graded according to standard histological criteria) |
| Secondary | Changes in coagulation parameters | Daily from Day 0 until end of perfusion, up to 14 days | Monitoring of coagulation function including prothrombin time (PT), activated partial thromboplastin time (APTT), INR, fibrinogen, and platelet count to evaluate the porcine liver's ability to synthesize coagulation factors and detect any xenogeneic coagulopathy or thrombotic microangiopathy. |
| Secondary | Inflammatory cytokine levels and immune cell subsets | Every 2 days from Day 0 until end of perfusion, up to 14 days | Measurement of inflammatory markers (interleukin-6, tumor necrosis factor-alpha, procalcitonin) and lymphocyte subsets (CD2, CD3, CD4, CD8, CD19, CD25) to assess systemic inflammatory response syndrome (SIRS) and immune activation during xenogeneic perfusion. |
| Secondary | Risk of cross-species viral transmission | Daily from Day 0 until 7 days after perfusion discontinuation | Daily testing for porcine endogenous retrovirus (PERV) and porcine cytomegalovirus (PCMV) in participant blood samples to evaluate the risk of zoonotic infection during extracorporeal perfusion. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07519005
GET https://conductscience.org/api/trials/v1/NCT07519005/registered