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

RecruitingPhase 1, Phase 2Ages any - anyAllBeijing Friendship Hospital
NCT07312864 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Chemically induced pluripotent stem cells biological Artificial Liver
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Where

1 site
Beijing Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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