Status:
RECRUITING
Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
Lead Sponsor:
Kebo Zhong
Conditions:
Liver Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06904755
Start Date
April 23 2024
End Date
December 30 2026
Last Update
April 1 2025
Active Locations (1)
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1
Zhujiang hospital
Guangzhou, Guangdong, China, 510000