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This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSC infusion | Experimental | UC-MSC infusion by intravenus, 1*10^8 cells/dose, 2 doses (apart from 24weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSC infusion | Drug | UC-MSC infusion by introvenus |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Changes from baseline to 72 weeks | |
| HBV-DNA | Changes from baseline to 72 weeks | |
| incidence of liver cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxi Huang, PHD | Contact | 86-0898-66151200 | huangxiaoxi@xibaozhiliao.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haikou People's Hospital | Recruiting | Haikou | China |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |