Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome

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 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

Conditions3

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