Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

NCT05106972 | Unknown

• 1 other identifier: SCT20181032
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (1)

UC-MSC infusion

EXPERIMENTAL

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

Drug: UC-MSC infusion

Interventions

UC-MSC infusion DRUG

UC-MSC infusion by introvenus

UC-MSC infusion

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Haikou People's Hospital

Haikou, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaoxi Huang, PHD

CONTACT

86-0898-66151200; huangxiaoxi@xibaozhiliao.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: November 4, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

CN (1)