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
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- 入组人数
- 54
- 主要终点
- Dose-limiting toxicity (DLT)
概览
简要总结
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MSCs treatment group
Human umbilical cord mesenchymal stem cells injection is a human expanded umbilical cord mesenchymal stem cells suspension
干预措施: Human umbilical cord mesenchymal stem cells injection (Biological)
Placebo-control group
Saline solution
干预措施: saline solution (Other)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 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.
Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis
时间窗: 3 months
Phase2: Observation the primary patency rate and secondary patency rate of the AVF after administration of human umbilical cord mesenchymal stem cells
次要结局
- Primary patency rate and secondary patency rate(1 year)
- Incidence of infection complications(1 year)