Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: UC-MSC infusion

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoxi Huang, PHD; Phone Number: 86-0898-66151200; Email: huangxiaoxi@xibaozhiliao.cn

Study Locations

• China
  • Haikou, China
    • Recruiting
    • Haikou People's Hospital
    • Contact: Xiaoxi Huang, PHD; Phone Number: 86-0898-66151200; Email: huangxiaoxi@xibaozhiliao.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: October 31, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Fibrosis; Hepatitis B; Liver Cirrhosis
• Other Study ID Numbers: SCT20181032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No