Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Tolerance
研究概览
简要总结
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to organic erectile dysfunction, such as those associated with metabolic syndrome or the treatment of prostate cancer.
详细描述
By enrolling patients with organic erectile dysfunction adapted to enrolled criteria, this study will document for the first time the safety and efficacy of underlying penile cellular damage.
The safety will be evaluated by tolerance degree. The efficacy will be evaluated validated scores and color duplex Doppler ultrasound.
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)
盲法说明
Different patients receive different numbers of cell for treatment per time
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Metabolic and systemic changes in diseases such as diabetes and atherosclerosis or more localized causes such as direct injury to the penile neurovascular supply during prostate surgery
- •Diagnosed as an organic erectile dysfunction by at least 2 urological surgeons
排除标准
- •Non-organic erectile dysfunction, such as psychological factors
- •Solid cancer patients other than early prostate cancer
- •Blood disease patients, thrombocytopenia or dysfunction, hypofibrinogenemia or anticoagulant therapy, long-term use of aspirin
- •Older than 70 years
结局指标
主要结局
Tolerance
时间窗: 1-4 weeks after each injection
Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
次要结局
- Short-term effects on erectile function(3-6 months after each injection)
- Long-term effects on erectile function(12 months after final injection)