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There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.
This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC group | Experimental | mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8. |
|
| control | No Intervention | Standard medication for viral hepatitis and cirrhosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cell transplantation via peripheral vein | Procedure | 1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Change of liver functions as assessed by MELD score | Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43) | 1 year |
| Safety: Adverse events as assessed according to CTCAE 4.03 | Adverse events as assessed according to CTCAE 4.03 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Benefit: Survival Rate at different time points | survival rate at different time points | 1 year, 2 year and 5 years |
| Histological change of the liver: Histological scores assessed by liver biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changcun Guo, MD | Contact | 862984771539 | guochc@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Disease, Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Outcome assessors will be blind to the randomization results of the participants.
| mesenchymal stem cell | Other | mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China |
|
histological scores assessed by liver biopsy at baseline and after treatment
| 1 year, 2 year and 5 years |
| Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy | Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy | 1, 2 and 5 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |