A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
54
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.
Phase 2: Saline solution will be given at the same quantity and following the same schedule
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
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
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
Incidence of infection complications
Observation the incidence of infection complications after AVF surgery
Time frame: 1 year
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