NCT06167473

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• End-stage Liver Diseases

Interventions

Type	Name	Description
BIOLOGICAL	umbilical cord-mesenchymal stem cells	Different dosage of umbilical cord-mesenchymal stem cells through peripheral vein

Timeline

• Start date: 2023-11-28
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-12-12
• Last updated: 2026-04-03

Locations

1 site across 1 country: China