Liver Cirrhosis
Conditions
Brief summary
This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.
Interventions
DRUGUC-MSC infusion
UC-MSC infusion by introvenus
Sponsors
Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 20 and 60 (male or female) * Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years * Not suitable for liver transplantation or there is no donor liver source * No serious bleeding tendency or active bleeding * No hepatic encephalopathy * After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score * Subjects voluntarily participate in this study and sign informed consent
Exclusion criteria
* Be less than 20 years old or more than 60 years old * Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis * Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives * Patients with hypersplenism who need splenectomy * History of tumors in other organs * PT prolongation is greater than 3 seconds * Use of human serum albumin within 3 weeks prior to clinical registration * Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration * Spontaneous peritonitis * Active infection (viral or bacterial) * Pregnant or lactating women * The researcher considers it inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with abnormal Total bilirubin | Changes from baseline to 72 weeks |
| Number of Participants with abnormal albumin | Changes from baseline to 72 weeks |
| Ishak Inflammation Rating System | Changes from baseline to 72 weeks |
| Ishak Fibrosis Score | Changes from baseline to 72 weeks |
Secondary
| Measure | Time frame |
|---|---|
| portal vein flow rate | Changes from baseline to 72 weeks |
| portal vein width | Changes from baseline to 72 weeks |
| incidence of liver cancer | Changes from baseline to 72 weeks |
| Number of Participants with abnormal coagulation function | Changes from baseline to 72 weeks |
| abdominal volume | Changes from baseline to 72 weeks |
| Number of Participants with abnormal immunoglobulin | Changes from baseline to 72 weeks |
| Overall survival (OS) | Changes from baseline to 72 weeks |
| HBV-DNA | Changes from baseline to 72 weeks |
Countries
China
Contacts
Primary ContactXiaoxi Huang, PHD
Outcome results
None listed