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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Not yet enrolling

Conditions: End-Stage Liver Diseases

Treatments: Other: Infusion of umbilical cord-mesenchymal stem cells through peripheral veins; Other: Infusion of umbilical cord-mesenchymal stem cells through hepatic artery

Study type: Interventional

Funder types: Other

Identifiers

NCT06984497

XHNKKY-DRSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-80 years old

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2. End-stage liver disease

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3. Signed informed consent

Exclusion criteria

1. Tumours of the liver or other organs

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2. Liver transplantation recipients

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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

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4. Other diseases that may seriously affect the survival

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5. Human immunodeficiency syndrome

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6. Interferon or glucocorticoid therapy within 1 year

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7. Treated for mental illness

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8. Participation in other clinical trials within 30 days

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9. Pregnant or breastfeeding subjects

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

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11. Other circumstances that are unsuitable for participation in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Peripheral veins infusion group

Experimental group

Description:

Peripheral veins infusion of stem cells

Treatment:

Other: Infusion of umbilical cord-mesenchymal stem cells through peripheral veins

Hepatic arterial infusion group

Experimental group

Description:

Hepatic arterial infusion of stem cells

Treatment:

Other: Infusion of umbilical cord-mesenchymal stem cells through hepatic artery