Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome
Recruiting now · Phase 1/Phase 2
Conditions studied: Liver Failure, Small-for-Size Syndrome
In brief
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.
Key facts
- Study ID
- NCT07312864
- Run by
- Beijing Friendship Hospital
- People needed
- 12
- Starts
- 2025-12-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-04-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients diagnosed with liver failure (including acute, subacute/acute-on-chronic, and chronic liver failure) or small-for-size syndrome
You may not qualify if…
- 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
Where it is running
- Beijing Friendship Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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