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

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).

Study Overview

• Status: Recruiting
• Conditions: Liver Failure
• Intervention / Treatment: Device: It is loaded with a mesenchymal stem cells reaction device for blood purification

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kebo Zhong, doctor; Phone Number: 8615360629197; Email: zhongkb@smu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhujiang Hospital
      • Contact: Zhong Kebo, doctor; Phone Number: 8615360629197; Email: zhongkb@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 bilirubin (TBil) ≥ 171μmol/L or an increase of ≥ 17.1μmol/L per day;
4. Prothrombin activity (PTA) between 20% and 40% (or INR 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 informed consent form before the experiment.

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, autoimmune 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood purification with mesenchymal stem cells therapy group	Device: It 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate on day 28 after treatment	researchers record all participators' survival condition from enrollment to day 28 after treatment.	From enrollment to day 28 after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conversion rate to liver transplantation	researchers record participators' condition of conversion to liver transplantation from enrollment to day 28, 56, 84 after treatment.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Throughout the entire course of MSC-based blood purification therapy.

Collaborators and Investigators

• Sponsor: Kebo Zhong

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency; Liver Failure
• Other Study ID Numbers: Zhujiang Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No