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Clinical Trials in China / NCT06904755
Recruiting Phase 1

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

NCT06904755 · tracked via the Priya Life Science China tracker
Sponsor
Kebo Zhong
Phase
Phase 1
Started
2024-04-23
Last updated
2026-04-15

Condition(s) studied

Liver Failure

Investigational drug(s) / intervention(s)

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

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Survival rate on day 28 after treatment — From enrollment to day 28 after treatment.
    researchers record all participators' survival condition from enrollment to day 28 after treatment.

Trial sites (1)

FacilityCityRegionStatus
Zhujiang hospital Guangzhou Guangdong Recruiting

Other trials for the same condition

A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF) Recruiting
Bidirectional Cohort Study of a Prognosis Model for Acute-on-chronic Liver Failure Active, not recruiting
Registry Study for Optimal Management of Liver Failure in the Chinese Population Recruiting
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure Recruiting
Fecal Microbiota Transplantation for Liver Failure Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06904755 on ClinicalTrials.gov ↗ ← All trials in China