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

March 1, 2026 updated by: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Day 28
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
Time Frame: 3 months
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
Time Frame: 1 year
Observation the primary patency rate and secondary patency rate of the AVF after surgery.
1 year
Incidence of infection complications
Time Frame: 1 year
Observation the incidence of infection complications after AVF surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe