hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

Study Overview
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Brief Summary
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Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.

Detailed Description
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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.

Official Title
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Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Peripheral iv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value; The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points. Have not received stem cell therapy in the recent 6 months; Subjects will be able to sign the informed consent in accordance with the study procedures and instructions. Exclusion Criteria: Insufficiency of vital organs, such as heart, kidney and lung; End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc. Concomitant peritonitis, pneumonia, or other types of infection not under control; Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine; Positive serum HIV antibody and syphilis antibody; Alpha fetoprotein>400ng/mL with primary liver cancer or without imaging evidence; Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ; Patients with severe mental illness and cognitive impairment;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6*10^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 * 10 ^ 7 (30 ml) | Biological: Peripheral iv<br>* 6*10^7 cells<br>|
| No Intervention: Control Group<br>Control Group: Using basic contrast . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity 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 | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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% | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Cirrhosis, mesenchymal stem cell