Status:
RECRUITING
hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
Lead Sponsor:
Sclnow Biotechnology Co., Ltd.
Conditions:
Hepatitis B
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 hum...
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 1...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03826433
Start Date
October 1 2018
End Date
December 31 2026
Last Update
November 24 2025
Active Locations (1)
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1
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008