NCT03886402撤回不适用
Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •history of ED of at least 3 months' duration
- •have been taking a Phosphodiesterase type 5 (PDE5) inhibitor for at least 1 month prior and willing to stop taking any PDE5 inhibitor for duration of study
- •have an IIEF-EF domain score that is ≥11 and ≤25
- •have the same sexual partner for the duration of the study
- •subject and partner willing to voluntarily give consent
- •speak, read and understand English
排除标准
- •non-responders to PDE5 inhibitor
- •radical prostatectomy or other pelvic surgery or penile implant
- •currently taking blood thinners, cancer drugs or HIV drugs
- •allergic to lidocaine, epinephrine, valium
- •diminished decision-making capacity
- •use of tobacco
- •previous pelvic or abdominal radiation therapy
- •anti-androgen therapy
- •untreated hypogonadism
- •uncontrolled hypertension or hypotension
- •unstable cardiovascular disease
- •systemic autoimmune disorder
研究组 & 干预措施
Treatment
Experimental
Each subject will receive a single injection of autologous adipose-derived stromal vascular fraction (SVF) and will be monitored for 6 months
干预措施: GID SVF-2 (Device)
结局指标
主要结局
Adverse Events
时间窗: 1 year
Monitoring of adverse events
次要结局
- International Index of Erectile Function (IIEF)(Pre-treatment, 30 days, 3 months and 6 months)
研究者
研究点 (1)
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