Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged between 20 and 60 (male or female)
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Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years
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Not suitable for liver transplantation or there is no donor liver source
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No serious bleeding tendency or active bleeding
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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
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Subjects voluntarily participate in this study and sign informed consent
Exclusion Criteria:
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Be less than 20 years old or more than 60 years old
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Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis
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Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives
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Patients with hypersplenism who need splenectomy
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History of tumors in other organs
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PT prolongation is greater than 3 seconds
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Use of human serum albumin within 3 weeks prior to clinical registration
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Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration
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Spontaneous peritonitis
-
Active infection (viral or bacterial)
-
Pregnant or lactating women
-
The researcher considers it inappropriate to participate in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Haikou People's Hospital | Haikou | China |
Sponsors and Collaborators
- Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCT20181032