Liver FailurePhase 1NCT06904755
Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
A Phase 1 study testing It is loaded with a mesenchymal stem cells reaction device for blood purification in people with Liver Failure, run by Kebo Zhong at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. It will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Failure
- What is being tested?
- It is loaded with a mesenchymal stem cells reaction device for blood purification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2024to 30 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 range from 18 to 65 years old;
- Patients with acute liver failure in the early and intermediate stages caused by various reasons;
- Total bilirubin (TBil) ≥ 171μmol/L or an increase of ≥ 17.1μmol/L per day;
- Prothrombin activity (PTA) between 20% and 40% (or INR between 1.5 and 2.6);
- No hepatic encephalopathy or encephalopathy below grade II (including grade II);
- Elevated inflammatory markers (IL-6 / TNF-α / CRP, etc.);
- The subjects are able to communicate well with the researchers and can complete the study in accordance with the study regulations;
- The subjects must be informed of this study and voluntarily sign a written informed consent form before the experiment.
Who cannot join
- Patients with severe active bleeding or diffuse intravascular coagulation;
- Patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine;
- Patients with circulatory failure;
- Patients with a MELD score > 30;
- Patients with other severe heart diseases, lung diseases, blood diseases, autoimmune diseases, or diabetes;
- Subjects who may be unable to complete this study for other reasons or who the researchers believe should not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang hospital
Guangzhou, Guangdong, 510000
Zhong Kebo, doctor, 8615360629197, zhongkb@smu.edu.cn
About this study
Official title: Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
The goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. It will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. The main questions it aims to answer are:1.Does mesenchymal stem cells in blood purification improve the condition of patients with liver failure? 2.What medical problems do participants have when taking mesenchymal stem cells in blood purification? Participants will receive routine medical treatment and blood purification treatment with mesenchymal stem cells.These cells work outside the body and do not enter the body. We will: 1.Collect samples from participants such as blood, Urine and feces. 2.record post-treatment outcomes such as survival rate at 4 weeks after treatment, conversion rate to liver transplantation, Inflammatory, survival rate at 7days, 14days, 8 weeks and 12 weeks after treatment, and liver disease indicators(prothrombin time activity percentage, lactic aicd, blood ammonia, α-fetoprotein, ferritin).
- Conditions
- Liver Failure
- Being tested
- It is loaded with a mesenchymal stem cells reaction device for blood purification
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It is loaded with a mesenchymal stem cells reaction device for blood purificationDevice
Artificial liver blood purification therapy is performed using a mesenchymal stem cells reactor.
| Study group | Role | What they receive |
|---|---|---|
| Blood purification with mesenchymal stem cells therapy group | Experimental | Not described Receives: Device: It is loaded with a mesenchymal stem cells reaction device for blood purification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate on day 28 after treatment
researchers record all participators' survival condition from enrollment to day 28 after treatment.
Measured: From enrollment to day 28 after treatment.
Secondary outcomes (12)
conversion rate to liver transplantation
researchers record participators' condition of conversion to liver transplantation from enrollment to day 28, 56, 84 after treatment.
Measured: From enrollment to day 28, 56, 84 after treatment.
Interleukin-6(IL-6)
Participators accept blood tests of a Inflammatory factor: reflect systemic inflammatory status.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Survival rate on day 7, 14, 56, 84 after treatment
Researchers record participators' survival condition from enrollment to day 7, 14, 56, 84 after treatment.
Measured: From enrollment to day 7, 14, 56, 84 after treatment.
lactic aicd
Participators accept blood tests of liver disease indicators lactic aicd from enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Model for End-Stage Liver Disease score
The internationally recognized prognostic scoring system for end-stage liver disease is used to determine prioritization for liver transplantation and predict patient survival rates.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Chinese group on the study of severe hepatitis B-acute-on-chronic liver failure score
To assess short-term mortality rates (28-day/90-day) in patients with acute-on-chronic liver failure (ACLF) and guide prioritization for liver transplantation and intensive care resource allocation.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
tumor necrosis factor α (TNF-α)
Participators accept blood tests of a Inflammatory factor: reflect systemic inflammatory status.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
C-reactive protein (CRP)
Participators accept blood tests of a Inflammatory factor: reflect systemic inflammatory status.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
blood ammonia
Participators accept blood tests of liver disease indicators blood ammonia from enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Alpha-fetoprotein (AFP)
Participators accept blood tests of liver disease indicators AFP from enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
ferritin
Participators accept blood tests of liver disease indicators ferritin from enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Measured: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Incidence rate of adverse events (AE incidence rate)
Record treatment-related adverse reactions occurring during the intervention.
Measured: Throughout the entire course of MSC-based blood purification therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start23 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kebo Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kebo Zhong, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904755
- Sponsor's protocol ID
- Zhujiang Hospital
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We fully acknowledge the significance of data sharing. However, owing to the policies and confidentiality agreements adhered to in our laboratory, we regretfully cannot furnish the raw data. Nevertheless, we have meticulously presented a comprehensive account of the experimental design, analysis, results, and the procedures employed for data analysis and processing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
- ClinicalTrials.gov ID
- NCT06904755
- Acronym / sponsor ID
- Zhujiang Hospital
- Conditions
- Liver Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kebo ZhongUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Apr 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 goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. It will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. The main questions it aims to answer are:1.Does mesenchymal stem cells in blood purification improve the condition of patients with liver failure? 2.What medical problems do participants have when taking mesenchymal stem cells in blood purification? Participants will receive routine medical treatment and blood purification treatment with mesenchymal stem cells.These cells work outside the body and do not enter the body. We will: 1.Collect samples from participants such as blood, Urine and feces. 2.record post-treatment outcomes such as survival rate at 4 weeks after treatment, conversion rate to liver transplantation, Inflammatory, survival rate at 7days, 14days, 8 weeks and 12 weeks after treatment, and liver disease indicators(prothrombin time activity percentage, lactic aicd, blood ammonia, α-fetoprotein, ferritin).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood purification with mesenchymal stem cells therapy group | Experimental | Device: It is loaded with a mesenchymal stem cells reaction device for blood purification |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range from 18 to 65 years old;
- Patients with acute liver failure in the early and intermediate stages caused by various reasons;
- Total bilirubin (TBil) ≥ 171μmol/L or an increase of ≥ 17.1μmol/L per day;
- Prothrombin activity (PTA) between 20% and 40% (or INR between 1.5 and 2.6);
- No hepatic encephalopathy or encephalopathy below grade II (including grade II);
Key exclusion criteria (6 listed)
- Patients with severe active bleeding or diffuse intravascular coagulation;
- Patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine;
- Patients with circulatory failure;
- Patients with a MELD score > 30;
- Patients with other severe heart diseases, lung diseases, blood diseases, autoimmune diseases, or diabetes;
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 |
|---|---|---|
| It is loaded with a mesenchymal stem cells reaction device for blood purificationArtificial liver blood purification therapy is performed using a mesenchymal stem cells reactor. | Device | Blood purification with mesenchymal stem cells therapy group |
Primary outcome
Survival rate on day 28 after treatment
Time frame: From enrollment to day 28 after treatment.
researchers record all participators' survival condition from enrollment to day 28 after treatment.
12 secondary outcomes
conversion rate to liver transplantation
Time frame: From enrollment to day 28, 56, 84 after treatment.
Interleukin-6(IL-6)
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Survival rate on day 7, 14, 56, 84 after treatment
Time frame: From enrollment to day 7, 14, 56, 84 after treatment.
lactic aicd
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Model for End-Stage Liver Disease score
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Chinese group on the study of severe hepatitis B-acute-on-chronic liver failure score
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
tumor necrosis factor α (TNF-α)
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
C-reactive protein (CRP)
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
blood ammonia
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Alpha-fetoprotein (AFP)
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
ferritin
Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Incidence rate of adverse events (AE incidence rate)
Time frame: Throughout the entire course of MSC-based blood purification therapy.
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 15 Apr 2026.
- Individual participant dataSharing planned: No. We fully acknowledge the significance of data sharing. However, owing to the policies and confidentiality agreements adhered to in our laboratory, we regretfully cannot furnish the raw data. Nevertheless, we have meticulously presented a comprehensive account of the experimental design, analysis, results, and the procedures employed for data analysis and processing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing It is loaded with a mesenchymal stem cells reaction device for blood purification in people with Liver Failure, run by Kebo Zhong at 1 site in China.
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 8 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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?
Contact Kebo Zhong, doctor (8615360629197, zhongkb@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate on day 28 after treatment (time frame: From enrollment to day 28 after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.