Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome
NCT ID: NCT07312864
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2025-12-01
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CiPS-BAL
Chemically induced pluripotent stem cells biological Artificial Liver
Chemically induced pluripotent stem cells biological Artificial Liver
Participants will receive CiPS-BAL therapy, a novel bioartificial liver treatment that combines functional hepatocytes derived from chemically induced pluripotent stem cells (CiPS) with an extracorporeal bioartificial liver device . The CiPS-derived hepatocytes are cultured and induced in vitro under GMP conditions, then loaded into the BAL device for treatment. Therapy is administered via central venous access (e.g., femoral, internal jugular, or subclavian vein) for 4-8 hours per session. Each patient receives approximately 1.67 × 10\^8 functional hepatocytes per kg of body weight, with treatment frequency and duration adjusted according to clinical response. Standard medical care for liver failure or small-for-size syndrome is provided alongside CiPS-BAL therapy. Patients are closely monitored for safety, tolerability, and changes in clinical and laboratory parameters.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chemically induced pluripotent stem cells biological Artificial Liver
Participants will receive CiPS-BAL therapy, a novel bioartificial liver treatment that combines functional hepatocytes derived from chemically induced pluripotent stem cells (CiPS) with an extracorporeal bioartificial liver device . The CiPS-derived hepatocytes are cultured and induced in vitro under GMP conditions, then loaded into the BAL device for treatment. Therapy is administered via central venous access (e.g., femoral, internal jugular, or subclavian vein) for 4-8 hours per session. Each patient receives approximately 1.67 × 10\^8 functional hepatocytes per kg of body weight, with treatment frequency and duration adjusted according to clinical response. Standard medical care for liver failure or small-for-size syndrome is provided alongside CiPS-BAL therapy. Patients are closely monitored for safety, tolerability, and changes in clinical and laboratory parameters.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Friendship Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Li-Ying Sun
Director of Department of Critical Liver Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Friendship Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Wan-Ting Zhang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BFH20251124001
Identifier Type: -
Identifier Source: org_study_id