NCT01804153Unknown1 期
Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Mesenchymal Stem Cells Use Derived From Adipose Tissue (ASC) for the Local Feminine Stress Urinary Incontinence
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence
研究概览
简要总结
Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence
详细描述
Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consen
- •Good general state of health according to the findings of ythe clinical history and the physical examination
- •Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide
- •Women having rejected de rehabilitation treatment or in which the treatment had failed
- •Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution
排除标准
- •Pregnant or lactating women
- •Active urine infection
- •Presenting an infravesical obstruction
- •Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
- •Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years
- •Cardiopulmonar 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 aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
- •Anesthesic allergy
- •Major surgery or severe trauma in the previous 6 months
- •Administration of any drug under experimentation in the present or 3 months before recruitement
研究组 & 干预措施
Autologous expanded stem cells
Experimental
Adipose-derived expanded stem cells
干预措施: Adipose-derived expanded stem cells (Drug)
结局指标
主要结局
Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence
时间窗: 16 weeks
compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra)
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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