Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.

Official Title
-----------------
A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: UC-MSC infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSC infusion<br>UC-MSC infusion by intravenus, 1*10^8 cells/dose, 2 doses (apart from 24weeks) | Drug: UC-MSC infusion<br>* UC-MSC infusion by introvenus<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | Changes from baseline to 72 weeks | 
| HBV-DNA |  | Changes from baseline to 72 weeks | 
| incidence of liver cancer |  | Changes from baseline to 72 weeks | 
| Number of Participants with abnormal immunoglobulin |  | Changes from baseline to 72 weeks | 
| portal vein flow rate |  | Changes from baseline to 72 weeks | 
| portal vein width |  | Changes from baseline to 72 weeks | 
| abdominal volume |  | Changes from baseline to 72 weeks | 
| Number of Participants with abnormal coagulation function |  | Changes from baseline to 72 weeks |