Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

Study Overview
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Brief Summary
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This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Detailed Description
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At present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.Stem cells from human exfoliated deciduous teeth (SHED) has been shown to be safe and effective for liver diseases. Randomization controlled studies are needed to confirm the long term effect of SHED treatment for liver cirrhosis. The present study aimed to investigate the safety and efficacy of SHED in hepatitis B related liver cirrhosis patients. This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). SHED infusion (1x10E6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Official Title
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Safety and Efficacy of Stem Cells From Human Exfoliated Deciduous Teeth for Treatment of Decompensated Liver Cirrhosis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Biological: SHED group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-70 years HBV-related liver cirrhosis with presentations of decompensation Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit; Child-Pugh score B and MELD-Na score≤25 Written consent Exclusion Criteria: Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis Child-Pugh score A or C Hepatocellular carcinoma or other malignancies Cirrhosis or liver failure caused by non-Hepatitis B Pregnancy or breastfeeding Severe bacteria infection,coinfection with HIV or other viral hepatitis. History of severe allergy to biological products or history of immunization within half a year Patients or family members refused to participate in the study Drug abuse or alcohol abuse 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: 70 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: SHED group<br>SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12. | Biological: SHED group<br>* 1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12<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 |
| --- | --- | --- |
| Model for End-Stage Liver Disease (MELD)-Na score | The MELD-Na score is a reliable measure of mortality risk in patients with end-stage liver disease. MELD-Na score=3.8ln[bilirubin (mg/dl)]+11.21ln(INR) +9.6ln[creatinine (mg/dl) +6.4* (cause: cholestasis and alcoholic cirrhosis are 0, others are 1) +1.59* (135-Na) | baseline and 4,8,12,16,24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child-Pugh score | The Child-Pugh score is a scoring system to measure the severity of chronic liver disease inclusive of cirrhosis. The point scores are added up and classified as: class A: 5-6 points class B: 7-9 points class C: 10-15 points The score is composed from several categories: total bilirubin, μmol/l (mg/dl)<34: 1 point 34-50: 2 points >50: 3 points serum albumin, g/l>35: 1 point 28-35: 2 points <28: 3 points INR<1.7: 1 point 1.7-2.3: 2 points >2.3: 3 points presence of ascites none: 1 point mild: 2 points moderate to severe: 3 points presence of hepatic encephalopathy none: 1 point grades I-II : 2 point grades III-IV: 3 point | baseline and 4,8,12,16,24 week | 
| Changes of liver function | Changes of liver function index such as ALT, AST, ALB, TBIL, PT | baseline and 4,8,12,16,24 week | 
| Changes of life quality | Changes of life quality as assessed by SF-36 | baseline and 4,8,12,16,24 week | 
| Survival Rate at half of one year | Survival rate at half of one year | half of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cirrhosis, stem cell, therapy