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Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Summary
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
Official title: A Prospective, Open-label and Single-arm Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2026-02-20
Completion Date
2028-03-30
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Human umbilical cord mesenchymal stem cells injection
Pahse 1: Patients will be enrolled into one of three cohorts to receive single injection of human umbilical cord mesenchymal stem cells injection(5×10\^5 cells × vascular surface area (cm²), 2.5×10\^6 cells × vascular surface area (cm²), 5×10\^6 cells × vascular surface area (cm²)). Phase 2: Based on the data obtained from Phase 1, the investigator will select one dose cohort to conduct study.
saline solution
Phase 2: Saline solution will be given at the same quantity and following the same schedule