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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhujiang hospital
RECRUITING
Guangzhou
Contact Information
Primary
Kebo Zhong, doctor
zhongkb@smu.edu.cn
8615360629197
Time Frame
Start Date: 2024-04-23
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 10
Treatments
Experimental: Blood purification with mesenchymal stem cells therapy group
Related Therapeutic Areas
Sponsors
Leads: Kebo Zhong

This content was sourced from clinicaltrials.gov