A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Hemodialysis outflow vein diameter
研究概览
简要总结
The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 18 and 85 years old
- •Patient currently on hemodialysis or pre-dialysis and planned creation of an upper extremity AV fistula with suitable anatomy
- •Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
- •Life expectancy of at least 24 months
排除标准
- •Malignancy or treatment for malignancy within the previous 6 months
- •Immunodeficiency including AIDS / HIV or Active autoimmune disease
- •Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
- •Pregnancy or breast feeding
- •Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF
- •Employees of the sponsor or patients who are employees or relatives of the investigator
- •History of failed organ transplant on immunosuppression
研究组 & 干预措施
Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)
干预措施: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC) (Biological)
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula
Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF
干预措施: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC) (Biological)
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula
Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF
干预措施: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC) (Biological)
Placebo treatment in brachiobasilic arteriovenous fistula
Subjects will receive placebo at first and second stage of BBF
干预措施: Placebo (Drug)
No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Patients receive standard of care.
结局指标
主要结局
Hemodialysis outflow vein diameter
时间窗: Baseline to 12 months after AVF creation
Diameter of outflow vein by ultrasound
次要结局
- Hemodialysis AVF Blood flow(Baseline to 12 months after AVF creation)