Acute-On-Chronic Liver FailurePhase 1NCT06996392

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

A Phase 1 study testing Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）, Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours） and Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours） in people with Acute-On-Chronic Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acute-On-Chronic Liver Failure
What is being tested?: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）, Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours） and Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteChina
Study dates: 7 May 2025to 31 Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

China1 site

Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630

Other trials in China

About this study

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

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.

Conditions: Acute-On-Chronic Liver Failure
Being tested: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）, Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours）, Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）, Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（Multiple-treatment）
Keywords: Acute -On-Chronic Liver Failure, Bio-artificial liver, Mesenchymal stem cells
Medical subject headings: Acute-On-Chronic Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）Combination product
The 4-hour group treatment session lasts 4 hours (±15 minutes). In the HBAL mode of the combined bioartificial liver device QH-1A, blood is initially filtered to separate the plasma, which is then pumped into a bioreactor. In this study, this bioreactor is uniquely filled with immortalized mesenchymal stem cells (PT-MSCs) optimized for blood purification. These cells are cultured to adhere to the outer surface of hollow fibers within the bioreactor, creating a stable and efficient living interface that continuously secretes bioactive factors such as exosomes.After passing through the bioreactor, the plasma is re-filtered and then returned to the patient's circulation via a dedicated pump.
Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours）Combination product
After the three subjects in the 4-hour group completed their 4-week follow-up, the Safety Evaluation Committee convened a meeting to review the safety data and determine whether to proceed with the recruitment for the 6-hour group.The 6-hour group treatment session lasts 6 hours (±15 minutes).The treatment procedure is identical to that of the 4-hour group.
Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）Combination product
After the three subjects in the 6-hour group completed their 4-week follow-up, the Safety Evaluation Committee convened a meeting to review the safety data and determine whether to proceed with the recruitment for the 8-hour group. The 8-hour group treatment session lasts 8 hours (±15 minutes).The treatment procedure is identical to that of the 4-hour group.
Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（Multiple-treatment）Combination product
Subjects in the multiple-treatment group will receive 2-3 sessions of bioartificial liver treatment; the number of sessions will be determined by the investigators based on the subjects' clinical needs. The treatment duration for each session will be set as the maximum tolerable period, as confirmed by the Safety Evaluation Committee based on 28-day safety observations from the 4-hour, 6-hour, and 8-hour groups. Each treatment session is administered following the procedure applied to patients in the group with the optimal tolerability duration.

Study groups in NCT06996392
Study group	Role	What they receive
4-hour group	Experimental	The 4-hour group will receive a single biological artificial liver treatment for 4 hours (±15 minutes). Receives: Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）
6-hour group	Experimental	The 6-hour group will receive a single biological artificial liver treatment for 6 hours (±15 minutes). Receives: Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours）
8-hour group	Experimental	The 8-hour group will receive a single biological artificial liver treatment for 8 hours (±15 minutes). Receives: Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）
Multiple-treatment group	Experimental	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. Receives: Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（Multiple-treatment）

What is being measured

The primary outcome is the main question the study is designed to answer.

Survival rate
Measured: 28-day

Secondary outcomes (5)

Combined Bioartificial Liver Device QH-1A Equipment Performance Pass Rate
Pass Criteria: If all items on the trial medical device evaluation are rated as "Yes," the device's performance is deemed acceptable. If any evaluation item is rated as "No," the device's performance is considered unacceptable. Reasons for any "No" ratings must be documented.
Measured: Day 1
Changes from the baseline in Child-Pugh grade
The Child-Pugh classification evaluation indicators consist of hepatic encephalopathy, ascites, total bilirubin, albumin, and prolonged PT time. The scoring and classification of the severity of Child-Pugh liver diseases are as follows:Grade A is 5 to 6 points. Grade B is 7 to 9 points. Grade C is 10 to 15 points. The higher the score, the worse the liver function.
Measured: 28-day
Changes from the baseline in COSSH-ACLF IIs
The Chinese Severe Hepatitis B Study Group (COSSH), based on a multicenter, open-label large cohort study, has established a novel prognostic scoring system for hepatitis B virus (HBV)-ACLF: COSSH-ACLF II s. A score of less than 7.4 indicates a low-risk group, a score between 7.4 and 8.4 indicates a moderate-risk group, and a score greater than 8.4 indicates a high risk of 28- and 90-day mortality.
Measured: 28-day
Changes from the baseline in MELD score
The MELD score (Model for End-Stage Liver Disease) is a scoring system used to assess the urgency of liver transplantation in chronic liver disease patients. The MELD score typically ranges from 6 to 40, with higher scores indicating more severe disease and a greater need for liver transplantation.
Measured: 28-day
The rate of bridging liver transplantation
Measured: 28-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 202531 Dec 2026

First posted30 May 2025
Study start7 May 2025
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06996392
Sponsor's protocol ID: PL20
Status last verified: May 2025
First submitted: 11 May 2025
Last updated: 30 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute-On-Chronic Liver Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06996392
Acronym / sponsor ID: PL20
Conditions: Acute-On-Chronic Liver Failure
Keywords: Acute -On-Chronic Liver Failure, Bio-artificial liver, Mesenchymal stem cells
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 15 participants (estimated)
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
Collaborators: Guangdong Qianhui Biotechnology Co., Ltd
Study start: 7 May 2025 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 30 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
4-hour group	Experimental	Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）The 4-hour group will receive a single biological artificial liver treatment for 4 hours (±15 minutes).
6-hour group	Experimental	Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours）The 6-hour group will receive a single biological artificial liver treatment for 6 hours (±15 minutes).
8-hour group	Experimental	Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）The 8-hour group will receive a single biological artificial liver treatment for 8 hours (±15 minutes).
Multiple-treatment group	Experimental	Combination Product: Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（Multiple-treatment）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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（4 hours）The 4-hour group treatment session lasts 4 hours (±15 minutes). In the HBAL mode of the combined bioartificial liver device QH-1A, blood is initially filtered to separate the plasma, which is then pumped into a bioreactor. In this study, this bioreactor is uniquely filled with immortalized mesenchymal stem cells (PT-MSCs) optimized for blood purification. These cells are cultured to adhere to the outer surface of hollow fibers within the bioreactor, creating a stable and efficient living interface that continuously secretes bioactive factors such as exosomes.After passing through the bioreactor, the plasma is re-filtered and then returned to the patient's circulation via a dedicated pump.	Combination product	4-hour group
Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（6 hours）After the three subjects in the 4-hour group completed their 4-week follow-up, the Safety Evaluation Committee convened a meeting to review the safety data and determine whether to proceed with the recruitment for the 6-hour group.The 6-hour group treatment session lasts 6 hours (±15 minutes).The treatment procedure is identical to that of the 4-hour group.	Combination product	6-hour group
Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（8 hours）After the three subjects in the 6-hour group completed their 4-week follow-up, the Safety Evaluation Committee convened a meeting to review the safety data and determine whether to proceed with the recruitment for the 8-hour group. The 8-hour group treatment session lasts 8 hours (±15 minutes).The treatment procedure is identical to that of the 4-hour group.	Combination product	8-hour group
Combining the QH-1A bioartificial liver device with mesenchymal stem cells for blood purification（Multiple-treatment）Subjects in the multiple-treatment group will receive 2-3 sessions of bioartificial liver treatment; the number of sessions will be determined by the investigators based on the subjects' clinical needs. The treatment duration for each session will be set as the maximum tolerable period, as confirmed by the Safety Evaluation Committee based on 28-day safety observations from the 4-hour, 6-hour, and 8-hour groups. Each treatment session is administered following the procedure applied to patients in the group with the optimal tolerability duration.	Combination product	Multiple-treatment group

Primary outcome

Survival rate
Time frame: 28-day

5 secondary outcomes

Combined Bioartificial Liver Device QH-1A Equipment Performance Pass Rate
Time frame: Day 1
Changes from the baseline in Child-Pugh grade
Time frame: 28-day
Changes from the baseline in COSSH-ACLF IIs
Time frame: 28-day
Changes from the baseline in MELD score
Time frame: 28-day
The rate of bridging liver transplantation
Time frame: 28-day

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
Individual participant dataSharing planned: No

Related trials for Acute-On-Chronic Liver Failure

Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate (time frame: 28-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06996392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.