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This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy,
This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6*10^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 * 10 ^ 7 (30 ml) |
|
| Control Group | No Intervention | Control Group: Using basic contrast . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral iv | Biological | 6*10^7 cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validity evaluation by detection of the Model for end-stage Liver Disease score of participants | After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. 40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality <9 - 1.9% observed mortality | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation by detecting Blood routine | To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment | 12 month |
| Validity evaluation by detection of the child-pugh of participants |
| Measure | Description | Time Frame |
|---|---|---|
| Validity evaluation by detection of the coagulation function of participants | After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures. The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2. | 12 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Guo, doctor | Contact | 861064368977 | georgeguo@sclnow.com | |
| Xuegong Fan, doctor | Contact | 86731-84327392 | xgfan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuegong Fan, doctor | Xiangya Hospital of Central South University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35% |
| 12 month |
| Imaging examination |
After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT). |
| 12 month |
| Imaging examination | Fibro-Touch examination | 12 month |
| Safety evaluation by detecting adverse events and serious adverse events | To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment | 12 month |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |