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Not yet recruiting NCT07452822

Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease

Phase I / Phase II Interventional Arteriovenous Fistula Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Human umbilical cord mesenchymal stem cells injection, saline solution.
Who it may be relevant to
Registry conditions: Arteriovenous Fistula Stenosis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Day 28]
  • Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis [Time frame: 3 months]
Secondary outcome measures (2)
  • Primary patency rate and secondary patency rate [Time frame: 1 year]
  • Incidence of infection complications [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Diabetic nephropathy with estimated glomerular filtration rate (eGFR) < 15 mL/min·1.73m²;
  • Requirement for creation of primary forearm cephalic vein-radial artery autologous arteriovenous fistula ;
  • Vessel criteria: cephalic vein diameter ≥ 2.0 mm (after tourniquet inflation) and radial artery diameter ≥ 1.5 mm;
  • Subject agrees to comply with the study treatment plan and visit schedule, is voluntarily enrolled, and has provided written informed consent.

Exclusion criteria

  • Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;
  • Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;
  • Patients with a history of pacemaker implantation;
  • Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;
  • Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;
  • Subjects who have participated in, are currently participating in, or plan to participate in other interventional clinical trials within 30 days prior to screening or during the study period;
  • Any other conditions deemed inappropriate by the investigator for enrollment in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07452822 · TH-RD14-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗