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

April 22, 2026 updated by: Sclnow Biotechnology Co., Ltd.

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

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
        • Contact:
          • ShaLing Li, doctor
          • Phone Number: 8613975186154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Biological: Peripheral iv
6*10^7 cells
No Intervention: Control Group
Control Group: Using basic contrast .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity evaluation by detection of the Model for end-stage Liver Disease score of participants
Time Frame: 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
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation by detecting Blood routine
Time Frame: 12 month
To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment
12 month
Validity evaluation by detection of the child-pugh of participants
Time Frame: 12 month

After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.

Points Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%
12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity evaluation by detection of the coagulation function of participants
Time Frame: 12 month

After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures.

The time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.
12 month
Imaging examination
Time Frame: 12 month
After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).
12 month
Imaging examination
Time Frame: 12 month
Fibro-Touch examination
12 month
Safety evaluation by detecting adverse events and serious adverse events
Time Frame: 12 month
To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sclnow Biotechnology Co., Ltd.

Investigators

  • Study Director: Xuegong Fan, doctor, Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCLnow-XY-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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