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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 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

NCT07452822•Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

February 20, 2026

Primary Completion Date

March 30, 2027

Completion Date

March 30, 2028

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Arteriovenous Fistula Stenosis

Interventions

Human umbilical cord mesenchymal stem cells injection

BIOLOGICAL

saline solution

OTHER

Contacts

Jianhua Dong

CONTACT

02580864326 dongjianhua007@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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