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| Name | Class |
|---|---|
| The First Hospital of Hebei Medical University | OTHER |
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The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem cell with self and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures and classical therapy in patients liver cirrhosis will be evaluated and compared.
This study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. All the inclusion and exclusion criteria will be same and the data analysis will be complete by the epidemiological commissioner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell transplantation therapy | Experimental | umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients. |
|
| antiviral therapy | Active Comparator | Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose). Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell transplantation through interventional procedure | Procedure | interventional procedure once |
|
| Measure | Description | Time Frame |
|---|---|---|
| liver volume calculated by MRI | Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm. | baseline |
| change from baseline in liver volume calculated by MRI at 6 months | Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm. | 6 months after treatment |
| change from baseline in liver volume calculated by MRI at 12 months | Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm. | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| blood biochemistry |
| baseline, 1,3,6 and 12 months after treatment or transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| liver biopsy | The result of liver biopsy judged by the same one expert. | baseline,6 and 12 months after transplantation |
| gastroscopy | Observe and photograph the related varicose veins. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihua An, PhD | Contact | 0086-10-57976845 | doctoran2010@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yihua An, PhD | Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yihua An | Beijing | China |
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| antiviral therapy (lamivudine, other antiviral drugs) | Drug | lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose). |
|
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| blood test |
|
| baseline,1,3,6 and 12 months after treatment or transplantation |
| liver enzyme fiber spectrum |
| baseline,1,3,6 and 12 months after treatment or transplantation |
| coagulation |
| baselin,1,3,6 and 12 months after treatment or transplantation |
| portal vein and splenic vein measure | 1)Portal vein diameter (Dpv) 2）Portal vein maximum velocity (Vmaxpv) 3）Portal vein blood flow per minute (Qpv) 4) The splenic vein diameter (Dsv) 5) Splenic vein maximum flow velocity (Vmaxsv) 6) Splenic vein blood flow per minute (Qsv) | baseline,1,3,6 and 12 months after treatment or transplantation |
| estrogen and progestin in blood | estrogen and progestin | baseline,1,3,6 and 12 months after treatment or transplantation |
| baseline,6 and 12 months after treatment or transplantation |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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