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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Arteriovenous Fistula Stenosis
• Intervention / Treatment: Biological: Human umbilical cord mesenchymal stem cells injection; Other: saline solution

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jianhua Dong; Phone Number: 02580864326; Email: dongjianhua007@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;
2. Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;
3. Patients with a history of pacemaker implantation;
4. Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;
5. Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;
6. 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;
7. Any other conditions deemed inappropriate by the investigator for enrollment in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo-control group; Saline solution	Other: saline solution; Phase 2: Saline solution will be given at the same quantity and following the same schedule
Experimental: MSCs treatment group; Human umbilical cord mesenchymal stem cells injection is a human expanded umbilical cord mesenchymal stem cells suspension	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency rate and secondary patency rate	Observation the primary patency rate and secondary patency rate of the AVF after surgery.	1 year
Incidence of infection complications	Observation the incidence of infection complications after AVF surgery	1 year

Collaborators and Investigators

• Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: TH-RD14-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No