A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 planned for 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
- •If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed.
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
- •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
- •History of failed organ transplant on immunosuppression.
- •Subjects with known active infection (infection which is being treated)
研究组 & 干预措施
Adipose Derived Mesenchymal Stem Cells
Subjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment.
干预措施: Adipose Derived Mesenchymal Stem Cells (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: 12 months
Evaluate the safety of AMSC administration by assessing the number of participants to experience an adverse event as defined by inflammation, infection (local or systemic), aneurysm formation, clinically significant increase or decrease in blood flow or thrombosis formation as evaluated through physical exam and ultrasound.
次要结局
未报告次要终点
研究者
Houssam Farres, M.D.
Principal Investigator
Mayo Clinic