1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. 2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. 3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy, This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
6\*10\^7 cells
Xiangya Hospital Central South University
Changsha, Hunan, China
RECRUITINGValidity evaluation by detection of the Model for end-stage Liver Disease score of participants
After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. 40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality \<9 - 1.9% observed mortality
Time frame: 12 month
Safety evaluation by detecting Blood routine
To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment
Time frame: 12 month
Validity evaluation by detection of the child-pugh of participants
After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures. Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%
Time frame: 12 month
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