Not Yet RecruitingPhase 1/2

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

54 participantsStarted 2026-02-20

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Dose-limiting toxicity (DLT)

Timeframe: Day 28

Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis

Timeframe: 3 months

NCT IDNCT07452822

SponsorJiangsu Topcel-KH Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-30

Jianhua Dong

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.