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NOT YET RECRUITING
NCT07452822
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

OTHER

saline solution

Phase 2: Saline solution will be given at the same quantity and following the same schedule