NCT01648491已完成不适用
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Study-Related Adverse Events
研究概览
简要总结
Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.
详细描述
Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.
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
- 78 Years 至 82 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •urinary incontinence
- •failed urinary incontinence (UI) treatments
排除标准
- •does not meet inclusion criteria, gender and age limit
结局指标
主要结局
Study-Related Adverse Events
时间窗: 6 months
次要结局
- Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire(Baseline and 6 months)
- Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)(6 months)
- Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)(6 months)
研究者
Kenneth Peters, MD
Principal Investigator
William Beaumont Hospitals
研究点 (4)
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