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

Официальное название

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

Обзор

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

Вмешательства

• Биопрепарат 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.
• Другое saline solution
  Phase 2: Saline solution will be given at the same quantity and following the same schedule

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Day 28]
• Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis [Срок оценки: 3 months]

Вторичные конечные точки (2)

• Primary patency rate and secondary patency rate [Срок оценки: 1 year]
• Incidence of infection complications [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07452822 · TH-RD14-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗