NCT02665520Unknown2 期
Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction
Elaj medical centers3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Adverse Events that occur during or after the procedure to measure safety and tolerability
研究概览
简要总结
Autologous Fat Derived Stem Cell treatment of ED.
To assess safety and primary efficacy of stem cell infusion in refractory ED.
To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 40 years old and older suffering from moderate to sever erectile dysfunction -
排除标准
- •Inability to give informed consent or attend follow up
- •Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease
- •Viral disease from infectivity viewpoint
- •Major penile fibrosis or severe Peyronie's disease
- •Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)
- •Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI)
- •Prior systemic chemotherapy, or radiotherapy to donor or recipient area
- •Not in potentially active sexual relationship
- •Age less than 40 or over 70
结局指标
主要结局
Adverse Events that occur during or after the procedure to measure safety and tolerability
时间窗: 1 year
to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients
次要结局
未报告次要终点
研究者
Mohamad Habous
Dr Mohamad Habous
Elaj medical centers
研究点 (3)
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