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

NCT07452822 | Not Yet Recruiting Phase 1

• 1 other identifier: TH-RD14-01
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Arteriovenous Fistula Stenosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Primary patency rate and secondary patency rate

  1 year

• Incidence of infection complications

  1 year

Study Arms (2)

MSCs treatment group

EXPERIMENTAL

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

Placebo-control group

PLACEBO COMPARATOR

Saline solution

Other: saline solution

Interventions

Human umbilical cord mesenchymal stem cells injection BIOLOGICAL

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.

MSCs treatment group

saline solution OTHER

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

Placebo-control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jianhua Dong

CONTACT

02580864326; dongjianhua007@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 was a a prospective, single-arm, open-label study. Phase 2 was a prospective, randomized, placebo-controlled, and dose-escalation study.

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share