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NCT Number: NCT06167473

Effect of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With ESLD

There is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. However, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. At present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. Stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.

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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

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110840, China

About this study

Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year. The participants will be randomly divided into a low-dose stem cell group (1×10^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10^6cells/kg per infusion), which are infused by peripheral vein. The investigators will observe ALT, AST, ALP, TBIL, ALB, PT, INR, MELD score, and Child-Pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 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
  • Sign 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

umbilical cord-mesenchymal stem cells

Biological

Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein

Other names: UC-MSCs

Primary outcomes

  1. Survival rate

    Time frame: 1 year

    Number of subjects surviving after one year

Secondary outcomes

  1. Changes in liver function

    Time frame: 1, 4, 8, 12, 24, and 48 weeks

    The values of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum albumin, prothrombin time, and international normalized ratio and the scores of MELD and Child-Pugh

  2. Incidence of hepatic decompensation events

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Efficacy and Safety of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Diseases

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2023
Registry last updated
Apr 3, 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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