NCT06984497

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: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End-Stage Liver Diseases

Interventions

Type	Name	Description
OTHER	Infusion of umbilical cord-mesenchymal stem cells through peripheral veins	Umbilical cord-mesenchymal stem cells injected through peripheral veins
OTHER	Infusion of umbilical cord-mesenchymal stem cells through hepatic artery	Umbilical cord-mesenchymal stem cells injected through hepatic artery

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-05-22
• Last updated: 2025-08-24

Locations

1 site across 1 country: China