NCT07312864

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

A Clinical Trial Assessing the Safety, Tolerability, and Exploratory Efficacy of a Novel Bioartificial Liver Therapy in Patients With Liver Failure or Small-for-Size Syndrome

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Liver Failure
• Small-for-Size Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: China