Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: It is loaded with a mesenchymal stem cells reaction device for blood purification.
- Who it may be relevant to
- Registry conditions: Liver Failure. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
Overview
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).
Interventions
- Device 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.
Primary outcome measures
- Survival rate on day 28 after treatment [Time frame: From enrollment to day 28 after treatment.]
Secondary outcome measures (12)
- conversion rate to liver transplantation [Time frame: From enrollment to day 28, 56, 84 after treatment.]
- Interleukin-6(IL-6) [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- Survival rate on day 7, 14, 56, 84 after treatment [Time frame: From enrollment to day 7, 14, 56, 84 after treatment.]
- lactic aicd [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- Model for End-Stage Liver Disease score [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- Chinese group on the study of severe hepatitis B-acute-on-chronic liver failure score [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- tumor necrosis factor α (TNF-α) [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- C-reactive protein (CRP) [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- blood ammonia [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- Alpha-fetoprotein (AFP) [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- ferritin [Time frame: From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.]
- Incidence rate of adverse events (AE incidence rate) [Time frame: Throughout the entire course of MSC-based blood purification therapy.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhujiang hospital — Guangzhou
Identifiers
NCT: NCT06904755 · Zhujiang Hospital