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

NCT03826433 | Recruiting Phase 1

• 1 other identifier: SCLnow-XY-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
2. 2.Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat.
3. 3.Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.

Conditions

Hepatitis B

Keywords

Hepatitis B Cirrhosis, mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

• Validity evaluation by detection of the Model for end-stage Liver Disease score of participants

  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 Outcomes (2)

• Safety evaluation by detecting Blood routine

  12 month

• Validity evaluation by detection of the child-pugh of participants

  12 month

Other Outcomes (4)

• Validity evaluation by detection of the coagulation function of participants

  12 month

• Imaging examination

  12 month

• Imaging examination

  12 month

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Control Group: Using basic contrast .

Interventions

Peripheral iv BIOLOGICAL

6\*10\^7 cells

Treatment Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Xuegong Fan, doctor

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Lei Guo, doctor

CONTACT

861064368977; georgeguo@sclnow.com

Xuegong Fan, doctor

CONTACT

86731-84327392; xgfan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: February 1, 2019
• Study Start: October 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)