Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome
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
Beijing Friendship Hospital
12 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the safety and tolerability of a novel bioartificial liver (CiPS-BAL) in patients with liver failure or small-for-size syndrome. The study will also collect preliminary data on clinical outcomes and laboratory parameters during treatment. The main questions it aims to answer are: Is the novel bioartificial liver system safe and well tolerated in patients with liver failure or small-for-size syndrome? What effects does the treatment have on liver function and other clinical and laboratory indicators? Researchers will treat participants with the CiPS-BAL system, which uses hepatocytes derived from chemically induced pluripotent stem cells (CiPS) within a bioartificial liver device.
Eligibility
Inclusion Criteria1
- Patients diagnosed with liver failure (including acute, subacute/acute-on-chronic, and chronic liver failure) or small-for-size syndrome
Exclusion Criteria7
- 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
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Interventions
Participants will receive CiPS-BAL therapy, a novel bioartificial liver treatment that combines functional hepatocytes derived from chemically induced pluripotent stem cells (CiPS) with an extracorporeal bioartificial liver device . The CiPS-derived hepatocytes are cultured and induced in vitro under GMP conditions, then loaded into the BAL device for treatment. Therapy is administered via central venous access (e.g., femoral, internal jugular, or subclavian vein) for 4-8 hours per session. Each patient receives approximately 1.67 × 10\^8 functional hepatocytes per kg of body weight, with treatment frequency and duration adjusted according to clinical response. Standard medical care for liver failure or small-for-size syndrome is provided alongside CiPS-BAL therapy. Patients are closely monitored for safety, tolerability, and changes in clinical and laboratory parameters.
Locations(1)
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NCT07312864