NCT05106972
Recruiting
Not Applicable
A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.1 site in 1 country30 target enrollmentDecember 1, 2021
Overview
- Phase
- Not Applicable
- Intervention
- UC-MSC infusion
- Conditions
- Liver Cirrhosis
- Sponsor
- Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Ishak Inflammation Rating System
- Status
- Recruiting
- Last Updated
- 4 years ago
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.
Investigators
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)
Arms & Interventions
UC-MSC infusion
UC-MSC infusion by intravenus, 1\*10\^8 cells/dose, 2 doses (apart from 24weeks)
Intervention: UC-MSC infusion
Outcomes
Primary Outcomes
Ishak Inflammation Rating System
Time Frame: Changes from baseline to 72 weeks
Number of Participants with abnormal Total bilirubin
Time Frame: Changes from baseline to 72 weeks
Number of Participants with abnormal albumin
Time Frame: Changes from baseline to 72 weeks
Ishak Fibrosis Score
Time Frame: Changes from baseline to 72 weeks
Secondary Outcomes
- Number of Participants with abnormal immunoglobulin(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)
- 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)
- portal vein flow rate(Changes from baseline to 72 weeks)
Study Sites (1)
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