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NCT Number: NCT03826433

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

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Peripheral iv

Biological

6*10^7 cells

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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%

Other outcomes

  1. 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.

  2. Imaging examination

    Time frame: 12 month

    After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).

  3. Imaging examination

    Time frame: 12 month

    Fibro-Touch examination

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Guo, doctor

CONTACT

[email protected]

861064368977

Xuegong Fan, doctor

CONTACT

[email protected]

86731-84327392

Sponsors and collaborators

Lead sponsor

Sclnow Biotechnology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2019
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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