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

RECRUITINGPHASE1

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

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

NCT03826433•Sclnow Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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;

Locations (1)

Xiangya Hospital Central South University

Changsha, Hunan, China

Key Dates

Start Date

October 1, 2018

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2026

Last Updated

November 24, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatitis B

Interventions

Peripheral iv

BIOLOGICAL

Contacts

Lei Guo, doctor

CONTACT

861064368977 georgeguo@sclnow.com

Xuegong Fan, doctor

CONTACT

86731-84327392 xgfan@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

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