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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06984497

Enrollment

Registered

2025-05-22

Start date

2026-02-01

Completion date

2026-12-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Liver Diseases

Keywords

cirrhosis, end-stage liver diseases, umbilical cord-mesenchymal stem cells, randomized controlled trial

Brief summary

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.

Detailed description

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.

Interventions

OTHERInfusion of umbilical cord-mesenchymal stem cells through peripheral veins

Umbilical cord-mesenchymal stem cells injected through peripheral veins

OTHERInfusion of umbilical cord-mesenchymal stem cells through hepatic artery

Umbilical cord-mesenchymal stem cells injected through hepatic artery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. 18-80 years old \- 2. End-stage liver disease \- 3. Signed informed consent

Exclusion criteria

1. Tumours of the liver or other organs \- 2. Liver transplantation recipients \- 3. 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 \- 4. Other diseases that may seriously affect the survival \- 5. Human immunodeficiency syndrome \- 6. Interferon or glucocorticoid therapy within 1 year \- 7. Treated for mental illness \- 8. Participation in other clinical trials within 30 days \- 9. Pregnant or breastfeeding subjects \- 10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies \- 11. Severe coagulopathy or renal dysfunction \- 12. Other circumstances that are unsuitable for participation in this study

Design outcomes

Primary

Measure	Time frame	Description
Survival rate	24 weeks	Number of subjects surviving after 24 weeks

Secondary

Measure	Time frame	Description
Changes in Model for End-Stage Liver Disease (MELD) score	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.
Changes in Child-Pugh score	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.
Incidence of hepatic decompensation events	4, 12, and 24 weeks	Number of patients who developed gastrointestinal bleeding, ascites, and hepatic encephalopathy

Countries

China

Contacts

STUDY_DIRECTORXingshun Qi, MD

The General Hospital of Northern Theater Command Study Director

PRINCIPAL_INVESTIGATORLiyan Dong, MM