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

Phase 1

Recruiting

• Conditions: Hepatitis B
• Interventions: Biological: Peripheral iv

• Registration Number: NCT03826433
• Lead Sponsor: Sclnow Biotechnology Co., Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Peripheral iv	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)

Primary Outcome Measures

Name	Time	Method
Validity evaluation by detection of the Model for end-stage Liver Disease score of participants	12 month	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

Secondary Outcome Measures

Name	Time	Method
Validity evaluation by detection of the child-pugh of participants	12 month	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%
Safety evaluation by detecting Blood routine	12 month	To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment

Trial Locations

Locations (1)

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China