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| ID | Type | Description | Link |
|---|---|---|---|
| Jinling 01 | Other Identifier | Jinling Hospital |
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Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in liver cirrhosis patients with refractory ascites are very wretched. The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect and influence of MSCs in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous bone marrow mesenchymal stem cells transplantation | Active Comparator | Every patient is given 1x106 MSCs per kg infused via liver artery |
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| mesenchymal stem cells transplantation | Active Comparator | autologous bone marrow mesenchymal stem cells transplantation |
|
| stem cells transplantation | Experimental | autologous bone marrow mesenchymal stem cells transplantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous bone marrow mesenchymal stem cells transplantation | Biological | Autologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| change in immune function,liver function in blood | before and one to 12 weeks after therapy |
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Inclusion Criteria:Inclusion Criteria:
Aged 18~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.
Exclusion Criteria:
history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
Prothrombin time is less than 30s. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fangyu Wang, MD/PhD | Nanjing University | Study Director |
| Fangyu Wang, MD/PhD | Nanjin University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19455046 | Background | Kharaziha P, Hellstrom PM, Noorinayer B, Farzaneh F, Aghajani K, Jafari F, Telkabadi M, Atashi A, Honardoost M, Zali MR, Soleimani M. Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial. Eur J Gastroenterol Hepatol. 2009 Oct;21(10):1199-205. doi: 10.1097/MEG.0b013e32832a1f6c. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2015 | |
| Reset | Apr 29, 2015 |
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|
| autologous bone marrow msenchymal stem cells transplantation | Biological |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2015 | Apr 29, 2015 |
| ID | Term |
|---|---|
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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