New bioartificial liver for people with liver failure or small-for-size syndrome
Official title: A Clinical Trial Assessing the Safety, Tolerability, and Exploratory Efficacy of a Novel Bioartificial Liver Therapy in Patients With Liver Failure or Small-for-Size Syndrome
Run by Beijing Friendship Hospital · NCT07312864 · Data updated 2026-11-12
This trial will test a bioartificial liver using hepatocytes made from chemically induced pluripotent stem cells to see if it is safe and tolerated in people with liver failure or small-for-size syndrome.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT07312864 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with diagnosed liver failure (acute, subacute/acute-on-chronic, or chronic) or small-for-size syndrome who can give informed consent and do not have severe extrahepatic end-stage disease, uncontrolled infection, active bleeding, pregnancy/breastfeeding, known severe hypersensitivity to CiPS-derived products, or inability to obtain venous access are ideal candidates.
✕Probably not a fit
Patients with severe extrahepatic organ failure, uncontrolled infection or bleeding, peripheral vascular collapse preventing access, pregnancy or breastfeeding, known severe allergy to the cell product, or those unwilling to receive CiPSC-based therapy are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1/2 interventional study will treat participants who have acute, subacute/acute-on-chronic, or chronic liver failure or small-for-size syndrome with a bioartificial liver device containing CiPS-derived hepatocytes. Investigators will monitor patients closely for adverse events and tolerability during and after treatment while collecting laboratory measures of liver function and other clinical outcomes. The trial is primarily focused on safety and tolerability but will also gather preliminary signals about effects on liver function and clinical course. Treatment and follow-up will take place at Beijing Friendship Hospital with standardized monitoring protocols.
Why it matters
Potential benefit: If successful, the device could provide temporary liver support and improve liver function or clinical stability, potentially reducing complications or the need for urgent transplantation.
How similar studies have gone: Previous bioartificial liver approaches have shown mixed results, and using chemically induced pluripotent stem cell–derived hepatocytes in a BAL device is a novel approach with limited prior human data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with liver failure (including acute, subacute/acute-on-chronic, and chronic liver failure) or small-for-size syndrome Exclusion Criteria: * Presence of severe extrahepatic systemic end-stage diseases * Uncontrollable infection or active bleeding * Pregnant or breastfeeding women * History of allergy or known severe hypersensitivity to CiPSC-derived cell products or blood products * Peripheral vascular collapse leading to inability to obtain venous access or collect blood * Unable or unwilling to provide informed consent or unable to comply with study requirements * Unwilling to receive CiPSC-based therapy
Where it's running
-
Beijing Friendship Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Wan-Ting Zhang
- Email: 13699189579@163.com
- Phone: +86 13699189579
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.