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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* Positive serum HIV antibody and syphilis antibody;
* Alpha fetoprotein\>400ng/mL with primary liver cancer or without imaging evidence;
* Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ;
* Patients with severe mental illness and cognitive impairment;
Primary outcome measure(s)
Validity evaluation by detection of the Model for end-stage Liver Disease score of participants — 12 month 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
Trial sites (1)
Facility
City
Region
Status
Xiangya Hospital Central South University
Changsha
Hunan
Recruiting
More Sclnow Biotechnology Co., Ltd. trials in China
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.
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