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NCT Number: NCT06984497

Human Umbilical Cord-mesenchymal Stem Cells Via Different Transplantation Routes in ESLD

Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that human umbilical cord mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury.

Stem cell therapy for end-stage liver disease (ESLD) can be administered through various routes, among which hepatic artery and peripheral vein infusions are the most commonly used in clinical practice. The efficacy of hepatic artery infusion appears to be greater than that of peripheral vein infusion.

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Key information

Conditions

End-Stage Liver Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Thirty-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 6 months. They will be randomly assigned to peripheral vein infusion and hepatic arterial infusion of human umbilical cord mesenchymal stem cell groups. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score at weeks 4, 12, and 24 post-infusion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 years old

-

  • End-stage liver disease

-

  • Signed informed consent

Exclusion criteria

  • Tumours of the liver or other organs

-

  • Liver transplantation recipients

-

  • Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases

-

  • Other diseases that may seriously affect the survival

-

  • Human immunodeficiency syndrome

-

  • Interferon or glucocorticoid therapy within 1 year

-

  • Treated for mental illness

-

  • Participation in other clinical trials within 30 days

-

  • Pregnant or breastfeeding subjects

-

  • Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies

-

  • Other circumstances that are unsuitable for participation in this study

Treatment and study plan

Infusion of umbilical cord-mesenchymal stem cells through peripheral veins

Other

Umbilical cord-mesenchymal stem cells injected through peripheral veins

Infusion of umbilical cord-mesenchymal stem cells through hepatic artery

Other

Umbilical cord-mesenchymal stem cells injected through hepatic artery

Primary outcomes

  1. Survival rate

    Time frame: 24 weeks

    Number of subjects surviving after 24 weeks

Secondary outcomes

  1. Changes in Model for End-Stage Liver Disease (MELD) score

    Time frame: 4, 12, and 24 weeks

    The Model for End-Stage Liver Disease (MELD) score ranges from 6 to 40, with higher values indicating more severe liver dysfunction and an increased risk of mortality.

  2. Changes in Child-Pugh score

    Time frame: 4, 12, and 24 weeks

    The Child-Pugh score is categorized into class A (5-6 points), class B (7-9 points), and class C (≥10 points), reflecting progressive liver disease severity. Higher Child-Pugh scores are associated not only with increased mortality risk but also with a significantly higher incidence of complications, such as gastrointestinal bleeding and infections.

  3. Incidence of hepatic decompensation events

    Time frame: 4, 12, and 24 weeks

    Number of patients who developed gastrointestinal bleeding, ascites, and hepatic encephalopathy

Study contacts

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

Beilei Zhang, MM

CONTACT

[email protected]

15191080726

Xingshun Qi, MD

CONTACT

[email protected]

18909881019

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Efficacy and Safety of Different Transplantation Routes of Human Umbilical Cord-mesenchymal Stem Cells in Patients With End-stage Liver Disease

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 22, 2025
Registry last updated
Aug 24, 2025

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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