Status:
ACTIVE_NOT_RECRUITING
Phase I Trial of QH-1A Hybrid Bio-Artificial Liver With Ex Vivo Blood-Purifying MSCs in Acute-on-Chronic Liver Failure
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Guangdong Qianhui Biotechnology Co., Ltd
Conditions:
Acute-On-Chronic Liver Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The goal of this Phase I clinical trial is to evaluate the safety and efficacy of combining the QH-1A bioartificial liver device with mesenchymal stem cells（MSCs） for blood purification in treating pa...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years, irrespective of gender.
- Patients with acute-on-chronic liver failure, diagnosed according to the - - Guideline for diagnosis and treatment of liver failure (2024 version) in China.
- Subjects must provide informed consent prior to the study and voluntarily sign the written informed consent form.
- Subjects must be able to communicate effectively with the investigators and comply with the study protocol.
Exclusion
- Active bleeding or disseminated intravascular coagulation (DIC) that is not effectively controlled.
- Allergies to the blood products or medications used during treatment.
- Circulatory failure.
- Occurrence of myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months.
- A history of malignant tumors within the past 5 years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- Any other conditions that, in the opinion of the investigator, render the subject unsuitable for participation in the study.
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06996392
Start Date
May 7 2025
End Date
December 31 2026
Last Update
May 30 2025
Active Locations (1)
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1
Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510630