Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106972
• Other study ID #: SCT20181032
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2021
• Source: Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
• Contact: Xiaoxi Huang, PHD
• Phone: 86-0898-66151200
• Email: huangxiaoxi[@]xibaozhiliao.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis B
• Liver Cirrhosis

Intervention

Drug:
• UC-MSC infusion
UC-MSC infusion by introvenus

Locations

Country	Name	City	State
China	Haikou People's Hospital	Haikou

Sponsors (1)

Lead Sponsor	Collaborator
Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with abnormal Total bilirubin		Changes from baseline to 72 weeks
Primary	Number of Participants with abnormal albumin		Changes from baseline to 72 weeks
Primary	Ishak Inflammation Rating System		Changes from baseline to 72 weeks
Primary	Ishak Fibrosis Score		Changes from baseline to 72 weeks
Secondary	Overall survival (OS)		Changes from baseline to 72 weeks
Secondary	HBV-DNA		Changes from baseline to 72 weeks
Secondary	incidence of liver cancer		Changes from baseline to 72 weeks
Secondary	Number of Participants with abnormal immunoglobulin		Changes from baseline to 72 weeks
Secondary	portal vein flow rate		Changes from baseline to 72 weeks
Secondary	portal vein width		Changes from baseline to 72 weeks
Secondary	abdominal volume		Changes from baseline to 72 weeks
Secondary	Number of Participants with abnormal coagulation function		Changes from baseline to 72 weeks