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RecruitingNCT06904755Updated Apr 15, 2026

Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure

A Phase 1 interventional study of It is loaded with a mesenchymal stem cells reaction device for blood purification in Liver Failure, sponsored by Kebo Zhong. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Kebo Zhong · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2024, registered Jan 2025).
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Liver Failure

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03

In context

Liver Failure

190 studies on the registry are indexed under Liver Failure; 33 are open to participants now.

This study's planned enrollment of 10 is below the median of 57 across 113 interventional studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

This is the only study on the registry with Kebo Zhong as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age range from 18 to 65 years old;
  2. Patients with acute liver failure in the early and intermediate stages caused by various reasons;
  3. Total (TBil) ≥ 171μmol/L or an increase of ≥ 17.1μmol/L per day;
  4. Prothrombin activity (PTA) between 20% and 40% (or between 1.5 and 2.6);
  5. No hepatic encephalopathy or encephalopathy below grade II (including grade II);
  6. Elevated inflammatory markers (IL-6 / TNF-α / CRP, etc.);
  7. The subjects are able to communicate well with the researchers and can complete the study in accordance with the study regulations;
  8. The subjects must be informed of this study and voluntarily sign a written form before the experiment.

Exclusion criteria

Exclusion Criteria:

  1. Patients with severe active bleeding or diffuse intravascular coagulation;
  2. Patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine;
  3. Patients with circulatory failure;
  4. Patients with a MELD score > 30;
  5. Patients with other severe heart diseases, lung diseases, blood diseases, diseases, or diabetes;
  6. Subjects who may be unable to complete this study for other reasons or who the researchers believe should not be included.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Blood purification with mesenchymal stem cells therapy group

    Device: It is loaded with a mesenchymal stem cells reaction device for blood purification

Interventions

  • DeviceIt is loaded with a mesenchymal stem cells reaction device for blood purification

    Artificial liver blood purification therapy is performed using a mesenchymal stem cells reactor.

06

What researchers measure

Primary outcomes

  1. Survival rate on day 28 after treatment

    researchers record all participators' survival condition from enrollment to day 28 after treatment.

    Time frame: From enrollment to day 28 after treatment.

Secondary outcomes

  1. conversion rate to liver transplantation

    researchers record participators' condition of conversion to liver transplantation from enrollment to day 28, 56, 84 after treatment.

    Time frame: From enrollment to day 28, 56, 84 after treatment.

  2. Interleukin-6(IL-6)

    Participators accept blood tests of a Inflammatory factor: reflect systemic inflammatory status.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  3. 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.

    Time frame: From enrollment to day 7, 14, 56, 84 after treatment.

  4. 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.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  5. 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.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  6. 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.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  7. tumor necrosis factor α (TNF-α)

    Participators accept blood tests of a Inflammatory factor: reflect systemic inflammatory status.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  8. C-reactive protein (CRP)

    Participators accept blood tests of a Inflammatory factor: reflect systemic inflammatory status.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  9. 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.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  10. 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.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  11. ferritin

    Participators accept blood tests of liver disease indicators ferritin from enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

    Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.

  12. Incidence rate of adverse events (AE incidence rate)

    Record treatment-related adverse reactions occurring during the intervention.

    Time frame: Throughout the entire course of MSC-based blood purification therapy.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2025
First posted
Apr 1, 2025
StartActual
Apr 23, 2024
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 30, 2026
Last update
Apr 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06904755
Lead sponsor
Kebo Zhong
Responsible party
Kebo Zhong (doctor, Zhujiang Hospital) — Sponsor-investigator
First posted
Apr 1, 2025
Start date
Apr 23, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 15, 2026

Study contacts

Kebo Zhong, doctor
Contact
zhongkb@smu.edu.cn
8615360629197

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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