Phase I Trial of QH-1A Hybrid Bio-Artificial Liver With Ex Vivo Blood-Purifying MSCs in Acute-on-Chronic Liver Failure

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 1

Conditions: Acute-On-Chronic Liver Failure

Treatments: Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）; Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）; Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours）; Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（Multiple-treatment）

Study type: Interventional

Funder types: Other

Identifiers

NCT06996392

PL20

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

4-hour group

Experimental group

Description:

The 4-hour group will receive a single biological artificial liver treatment for 4 hours (±15 minutes).

Treatment:

Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）

6-hour group

Experimental group

Description:

The 6-hour group will receive a single biological artificial liver treatment for 6 hours (±15 minutes).

Treatment:

Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours）

8-hour group

Experimental group

Description:

The 8-hour group will receive a single biological artificial liver treatment for 8 hours (±15 minutes).

Treatment:

Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）

Multiple-treatment group

Experimental group

Description:

The Safety Evaluation Committee will determine the maximum tolerable treatment duration based on the 28-day safety observation outcomes from the 4-, 6-, and 8-hour groups. This duration will then be adopted as the treatment time for the multiple-treatment group. Subjects in the multiple-treatment group will undergo 2-3 treatments at this maximum duration, with an interval of 3 (±1) days between sessions.

Treatment:

Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（Multiple-treatment）