NCT07452822Not 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
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
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 1 Mar 2026
- Start date
- 20 Feb 2026
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Diseases
- Chronic kidney disease
- NCT number
- NCT07452822
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 54
- From 20 Feb 2026 to the primary completion date, 30 Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;
- Patients with a history of pacemaker implantation;
- Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;
- Any other conditions deemed inappropriate by the investigator for enrollment in this study.
Lab values
- Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;
Other
- Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.