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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJiangsu Topcel-KH Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Human umbilical cord mesenchymal stem cells injection
  • saline solution

Treatment groups

54 Participants
are divided into 2 treatment groups

Locations

This trial has no locations