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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.
In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and autologous PBSC transplantation can significantly improve liver synthetic function. But further studied was needed to confirm the safety and efficacy of PBSC transplantation. In this study, a prospective, randomized, parallel clinical study was designed. The patients with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | conventional treatment & antiviral treatment |
|
| conventional & PBSC transplantation | Experimental | After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBSC transplantation | Other | PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant via hepatic artery |
| 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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| ID | Term |
|---|---|
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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