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Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
UC-MSC infusion
Sponsored by
Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haikou People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UC-MSC infusion

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with abnormal Total bilirubin
Number of Participants with abnormal albumin
Ishak Inflammation Rating System
Ishak Fibrosis Score

Secondary Outcome Measures

Overall survival (OS)
HBV-DNA
incidence of liver cancer
Number of Participants with abnormal immunoglobulin
portal vein flow rate
portal vein width
abdominal volume
Number of Participants with abnormal coagulation function

Full Information

First Posted
September 19, 2021
Last Updated
October 31, 2021
Sponsor
Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05106972
Brief Title
Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
Official Title
A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UC-MSC infusion
Arm Type
Experimental
Arm Description
UC-MSC infusion by intravenus, 1*10^8 cells/dose, 2 doses (apart from 24weeks)
Intervention Type
Drug
Intervention Name(s)
UC-MSC infusion
Intervention Description
UC-MSC infusion by introvenus
Primary Outcome Measure Information:
Title
Number of Participants with abnormal Total bilirubin
Time Frame
Changes from baseline to 72 weeks
Title
Number of Participants with abnormal albumin
Time Frame
Changes from baseline to 72 weeks
Title
Ishak Inflammation Rating System
Time Frame
Changes from baseline to 72 weeks
Title
Ishak Fibrosis Score
Time Frame
Changes from baseline to 72 weeks
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Changes from baseline to 72 weeks
Title
HBV-DNA
Time Frame
Changes from baseline to 72 weeks
Title
incidence of liver cancer
Time Frame
Changes from baseline to 72 weeks
Title
Number of Participants with abnormal immunoglobulin
Time Frame
Changes from baseline to 72 weeks
Title
portal vein flow rate
Time Frame
Changes from baseline to 72 weeks
Title
portal vein width
Time Frame
Changes from baseline to 72 weeks
Title
abdominal volume
Time Frame
Changes from baseline to 72 weeks
Title
Number of Participants with abnormal coagulation function
Time Frame
Changes from baseline to 72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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) Pregnant or lactating women The researcher considers it inappropriate to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxi Huang, PHD
Phone
86-0898-66151200
Email
huangxiaoxi@xibaozhiliao.cn
Facility Information:
Facility Name
Haikou People's Hospital
City
Haikou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxi Huang, PHD
Phone
86-0898-66151200
Email
huangxiaoxi@xibaozhiliao.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

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