Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBeijing Friendship Hospital
About this trial
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 criteria
Qualifiers
Patients diagnosed with liver failure (including acute, subacute/acute-on-chronic, and chronic liver failure) or small-for-size syndrome
Disqualifiers
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
Trial design
Treatments tested in this trial
- Chemically induced pluripotent stem cells biological Artificial Liver
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov