1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. 2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. 3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value;
The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points.
Have not received stem cell therapy in the recent 6 months;
Subjects will be able to sign the informed consent in accordance with the study procedures and instructions.
Insufficiency of vital organs, such as heart, kidney and lung;
End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc.
Concomitant peritonitis, pneumonia, or other types of infection not under control;
Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;
Parallel
Peripheral iv
Biological/Vaccine6\*10\^7 cells
Validity evaluation by detection of the Model for end-stage Liver Disease score of participants
After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. 40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality \<9 - 1.9% observed mortality
Safety evaluation by detecting Blood routine
To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment
Validity evaluation by detection of the child-pugh of participants
After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%
Validity evaluation by detection of the coagulation function of participants
After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures. The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.
Imaging examination
After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).
Imaging examination
Fibro-Touch examination
Safety evaluation by detecting adverse events and serious adverse events
To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment
Click on the lead sponsor to view all of their trials.
