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

Last updated: July 18, 2024
Sponsor: Sclnow Biotechnology Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

Peripheral iv

Clinical Study ID

NCT03826433
SCLnow-XY-04
  • Ages 18-60
  • All Genders

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 Criteria

Inclusion

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 ofhepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and theliver function grade was child-pugh B or child-pugh C, with a score range of 7-12points, 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 studyprocedures and instructions.

Exclusion

Exclusion Criteria:

  • Insufficiency of vital organs, such as heart, kidney and lung;

  • End-stage cirrhosis with severe complications, including but not limited to: hepaticencephalopathy, 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 foodor 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 virusinfection, or other factors except chronic hepatitis B virus infection ;

  • Patients with severe mental illness and cognitive impairment;

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Peripheral iv
Phase: 1
Study Start date:
October 01, 2018
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

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