Overview
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 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
