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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Eastern Hepatobiliary Surgery Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
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HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.
Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.
Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC treatment for these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional | Active Comparator | conventional treatment & antiviral treatment |
|
| UC-MSC transplantation | Experimental | Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSC transplantation | Other | After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit |
| Measure | Description | Time Frame |
|---|---|---|
| one year survival rate | one year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MELD score | 1week, 4weeks,3months, 6months, 9months and 1year after treatment | |
| Child Pugh Score | 1week, 4weeks,3months, 6months, 9months and 1year after treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ying han | Contact | 86-29-84771539 | hanying@fmmu.edu.cn | |
| yongquan shi | Contact | 86-29-84771515 | shiyquan@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Daiming Fan | Air Force Military Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Disease | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| Fudan University |
| OTHER |
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| conventional treatment | Other | Participants will receive conventional treatment and antiviral treatment. |
|
| alpha fetoprotein |
| 1week, 4weeks,3months, 6months, 9months and 1year after treatment |
| renal function | 1week, 4weeks,3months, 6months, 9months and 1year after treatment |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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