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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

ConditionArteriovenous Fistula Stenosis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Human umbilical cord mesenchymal stem cells injection

    Biological/Vaccine

    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

    Other intervention

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

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: MSCs treatment groupExperimental treatment 1 intervention
Group B: Placebo-control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Phase1: Exploration of dose-limiting toxicity (DLT) and the optimal dose for the phase 2 after the admistration of human umbilical cord mesenchymal stem cells injection.

Time frame
Day 28
2

Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis

Phase2: Observation the primary patency rate and secondary patency rate of the AVF after administration of human umbilical cord mesenchymal stem cells

Time frame
3 months

Secondary outcomes

1

Primary patency rate and secondary patency rate

Observation the primary patency rate and secondary patency rate of the AVF after surgery.

Time frame
1 year
2

Incidence of infection complications

Observation the incidence of infection complications after AVF surgery

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: