Clinical trial NCT06996392: Phase I Trial of QH-1A Hybrid Bio-Artificial Liver With Ex Vivo Blood-Purifying MSCs in Acute-on-Chronic Liver Failure
Official title: Phase I Trial of QH-1A Hybrid Bio-Artificial Liver With Ex Vivo Blood-Purifying MSCs in Acute-on-Chronic Liver Failure: Safety, Efficacy, and Treatment Schedule Exploration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Acute-On-Chronic Liver Failure
Keywords: Acute -On-Chronic Liver Failure
Bio-artificial liver
Mesenchymal stem cells
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Qianhui Biotechnology Co., Ltd
First posted: 2025-05-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 patients with acute-on-chronic liver failure, and to determine the optimal treatment duration and frequency for Phase II. The study will enroll patients aged 18 to 65 years who meet the diagnostic criteria for acute-on-chronic liver failure as outlined in the 2024 Chinese Liver Failure Clinical Guidelines.

The main questions this study aims to answer are:

* Does the combined therapy improve the 28-day survival rate after the final treatment?
* Does the QH-1A device in its HBAL mode consistently achieve the predefined device performance pass rate?
* Do patients show significant improvements in their biochemical markers following treatment?
* What is the immunogenicity profile of the mesenchymal stem cells used for blood purification?

Participants will be screened within 14 days before their first treatment and will be allocated into one of four groups based on treatment duration and frequency:

* 4-hour group (3 patients)
* 6-hour group (3 patients)
* 8-hour group (3 patients)
* Multiple-treatment group (6 patients) Treatment will be administered in a sequential escalation-from the 4-hour group up to the multiple-treatment group-based on safety data from a 28-day observation period, which will be reviewed by a Safety Evaluation Committee. In addition, upon referral to the Hepatitis B Health Clinic, participants will receive tailored health education, comprehensive liver function and virological assessments, and an individualized treatment and follow-up plan.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Survival rate
timeFrame: 28-day
Secondary outcomes:
measure: Combined Bioartificial Liver Device QH-1A Equipment Performance Pass Rate
timeFrame: Day 1
measure: Changes from the baseline in Child-Pugh grade
timeFrame: 28-day
measure: Changes from the baseline in COSSH-ACLF IIs
timeFrame: 28-day
measure: Changes from the baseline in MELD score
timeFrame: 28-day
measure: The rate of bridging liver transplantation
timeFrame: 28-day
Other outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: 28-day
measure: Number of participants with positive infectious pathogens in the return fluid
timeFrame: Day1
measure: Number of participants with positive replicative lentivirus in the blood
timeFrame: Day1,Day28
measure: Number of participants in whom mesenchymal stem cell shedding was detected in the return fluid
timeFrame: Day1
measure: Changes from the baseline in immunogenicity indicators
timeFrame: Day1, Day7,Day28
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: