NCT01799694已完成2 期
Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Stem Cells Use Derived From Adipose Tissue (e-ASC) for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- •Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months
- •Having urinary incontinence after the surgery
- •Failure in any previous conservative treatment
排除标准
- •Having had an adjuvant treatment
- •Having a PSA ≥ 0,2 after surgery
- •Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma
- •Active urine infection
- •Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
- •Cardiopulmonary illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study
- •Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
- •Subjects with congenital or acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
- •Anesthetic allergy
- •Major surgery or severe trauma in the previous 6 months
- •Administration of any drug under experimentation in the present or in the previous 3 months before recruitment
研究组 & 干预措施
Autologous Expanded Stem Cells
Experimental
Inject of Autologous Adipose-derived expanded stem cells
干预措施: Inject of Autologous Adipose-derived stem cells (Drug)
结局指标
主要结局
Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
时间窗: 16 weeks
Possibility of inject ASc by cystoscope
次要结局
- Quality of life assessment using the SF-12 Questionnaire(1, 4, 16, 24 weeks)
- Adverse events(1, 4, 16, 24 weeks)
研究者
研究点 (1)
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