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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12
Changhai Hospital
Shanghai, Shanghai Municipality, China
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)
Time frame: baseline and 4,8,12,16,24 week
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
Time frame: baseline and 4,8,12,16,24 week
Changes of liver function
Changes of liver function index such as ALT, AST, ALB, TBIL, PT
Time frame: baseline and 4,8,12,16,24 week
Changes of life quality
Changes of life quality as assessed by SF-36
Time frame: baseline and 4,8,12,16,24 week
Survival Rate at half of one year
Survival rate at half of one year
Time frame: half of one year
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