Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

Not Applicable

Recruiting

• Conditions: Liver Cirrhosis
• Interventions: Drug: UC-MSC infusion

• Registration Number: NCT05106972
• Lead Sponsor: Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.

Brief Summary

This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-19
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-31
• Last Update Submitted: 2021-10-31
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04
• Study Start: 2021-12-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UC-MSC infusion	UC-MSC infusion	UC-MSC infusion by intravenus, 1\*10\^8 cells/dose, 2 doses (apart from 24weeks)

Primary Outcome Measures

Name	Time	Method
Ishak Inflammation Rating System	Changes from baseline to 72 weeks
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 Fibrosis Score	Changes from baseline to 72 weeks

Secondary Outcome Measures

Name	Time	Method
portal vein flow rate	Changes from baseline to 72 weeks
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

Trial Locations

Locations (1)

Haikou People's Hospital; 🇨🇳 Haikou, China