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Recruiting Phase 1

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

NCT03826433 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2018-10-01
Last updated
2026-04-23

Condition(s) studied

Hepatitis B

Investigational drug(s) / intervention(s)

Peripheral iv

Peripheral iv: 6\*10\^7 cells

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Xiangya Hospital Central South University Changsha Hunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03826433 on ClinicalTrials.gov ↗ ← All trials in China