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

NCT ID: NCT06904755

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-23
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blood purification with mesenchymal stem cells therapy group

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kebo Zhong

OTHER

Sponsor Role: lead

Responsible Party

Kebo Zhong

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhujiang hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kebo Zhong, doctor

Role: CONTACT

zhongkb@smu.edu.cn

8615360629197

Facility Contacts

Zhong Kebo, doctor

Role: primary

zhongkb@smu.edu.cn

8615360629197

Other Identifiers

Zhujiang Hospital

Identifier Type: -

Identifier Source: org_study_id