Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Wan-Ting Zhang
Data sourced from clinicaltrials.gov
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