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

Who is this study for? Patients with Chronic Hepatitis B
What treatments are being studied? Peripheral IV
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Xiangya Hospital Central South University
RECRUITING
Changsha
Contact Information
Primary
Lei Guo, doctor
georgeguo@sclnow.com
861064368977
Backup
Xuegong Fan, doctor
xgfan@hotmail.com
86731-84327392
Time Frame
Start Date: 2018-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Treatment Group
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)
No_intervention: Control Group
Control Group: Using basic contrast .
Related Therapeutic Areas
Sponsors
Leads: Sclnow Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov