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NCT Number: NCT06904755

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhujiang hospital

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Zhong Kebo, doctor

CONTACT

[email protected]

8615360629197

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. conversion rate to liver transplantation

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

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

  2. Interleukin-6(IL-6)

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

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

  3. Survival rate on day 7, 14, 56, 84 after treatment

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

    Researchers record participators' survival condition from enrollment to day 7, 14, 56, 84 after treatment.

  4. lactic aicd

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

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

  5. Model for End-Stage Liver Disease score

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

    The internationally recognized prognostic scoring system for end-stage liver disease is used to determine prioritization for liver transplantation and predict patient survival rates.

  6. 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.

    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.

  7. tumor necrosis factor α (TNF-α)

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

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

  8. C-reactive protein (CRP)

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

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

  9. blood ammonia

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

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

  10. Alpha-fetoprotein (AFP)

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

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

  11. ferritin

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

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

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

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

    Record treatment-related adverse reactions occurring during the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Kebo Zhong, doctor

CONTACT

[email protected]

8615360629197

Sponsors and collaborators

Lead sponsor

Kebo Zhong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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