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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

NCT07452822 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-05

No results posted yet for this study

Summary

A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis

Conditions

  • Arteriovenous Fistula Stenosis

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

Sponsors & Collaborators

  • Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2027-03-30
Completion
2028-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452822 on ClinicalTrials.gov