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

NCT06904755 | Recruiting Phase 1

• 1 other identifier: Zhujiang Hospital
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• conversion rate to liver transplantation

  From enrollment to day 28, 56, 84 after treatment.

• Interleukin-6(IL-6)

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

• Survival rate on day 7, 14, 56, 84 after treatment

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

• lactic aicd

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

• Model for End-Stage Liver Disease score

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

Study Arms (1)

Blood purification with mesenchymal stem cells therapy group

EXPERIMENTAL

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

Interventions

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.

Blood purification with mesenchymal stem cells therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kebo Zhong: lead

Study Sites (1)

Zhujiang hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Kebo Zhong, doctor

CONTACT

8615360629197; zhongkb@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: April 1, 2025
• Study Start: April 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)