Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: mesenchymal stem cell transplantation via peripheral vein
* Other: mesenchymal stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-65 years HBV -related liver cirrhosis Child-Pugh score ≥7 With presentations of decompensation Written consent Exclusion Criteria: Hepatocellular carcinoma or other malignancies Severe problems in other vital organs(e.g.the heart,renal or lungs) Pregnant or lactating women Severe bacteria infection Anticipated with difficulty of follow-up observation Coinfection with HIV or other viral hepatitis. Drug abuse or alcohol abuse History of severe allergy to biological products Other candidates who are judged to be not applicable to this study by doctors -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC group<br>mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8. | Procedure: mesenchymal stem cell transplantation via peripheral vein<br>* 1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8<br>Other: mesenchymal stem cell<br>* mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China<br>|
| No Intervention: control<br>Standard medication for viral hepatitis and cirrhosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cirrhosis, Mesenchymal Sem Cells