NCT07312864 Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome
| NCT ID | NCT07312864 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Friendship Hospital |
| Condition | Liver Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-12-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with liver failure (including acute, subacute/acute-on-chronic, and chronic liver failure) or small-for-size syndrome Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07312864 clinical trial?
This trial is open to participants of all sexes, studying Liver Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07312864 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07312864 currently recruiting?
Yes, NCT07312864 is actively recruiting participants. Contact the research team at 13699189579@163.com for enrollment information.
Where is the NCT07312864 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07312864 clinical trial?
NCT07312864 is sponsored by Beijing Friendship Hospital. The trial plans to enroll 12 participants.