Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure
ConditionLiver Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKebo Zhong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
It is loaded with a mesenchymal stem cells reaction device for blood purification
DeviceArtificial liver blood purification therapy is performed using a mesenchymal stem cells reactor.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Blood purification with mesenchymal stem cells therapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Survival rate on day 28 after treatment
researchers record all participators' survival condition from enrollment to day 28 after treatment.
Time frame
From enrollment to day 28 after treatment.Secondary outcomes
1
conversion rate to liver transplantation
researchers record participators' condition of conversion to liver transplantation from enrollment to day 28, 56, 84 after treatment.
Time frame
From enrollment to day 28, 56, 84 after treatment.2
Interleukin-6(IL-6)
Participators accept blood tests of a Inflammatory factor: reflect systemic inflammatory status.
Time frame
From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.3
Survival rate on day 7, 14, 56, 84 after treatment
Researchers record participators' survival condition from enrollment to day 7, 14, 56, 84 after treatment.
Time frame
From enrollment to day 7, 14, 56, 84 after treatment.4
lactic aicd
Participators accept blood tests of liver disease indicators lactic aicd from enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.
Time frame
From enrollment to day 1, 3, 5, 7, 14, 28, 56, 84 after treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kebo Zhong
Lead sponsor
Zhujiang Hospital
Sponsor institution
Source ClinicalTrials.gov