Actively Recruiting

Phase 1
Phase 2
All Genders
NCT07312864

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

Led by Beijing Friendship Hospital · Updated on 2026-04-20

12

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with liver failure (including acute, subacute/acute-on-chronic, and chronic liver failure) or small-for-size syndrome
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Friendship Hospital

Beijing, China, 101102

Actively Recruiting

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Research Team

W

Wan-Ting Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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