Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of cured patients
研究概览
简要总结
Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
详细描述
During the implementation of the project, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed.
Effectiveness of MSCs is due to the following:
- the ability of MSCs to stimulate tissue regeneration
- positive results of preclinical studies of the method of treatment of stress urinary incontinence (SUI) in animals (female rats).
After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area.
Injected volume was 3 ml per patient. For injection MSCs (6*10^6 cells) were mixed with collagen solution (3,5% w|w).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stress urinary incontinence
- •absence of acute inflammatory manifestations in the genitourinary system
排除标准
- •urethral or bladder malformations
- •acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- •mental disorders
结局指标
主要结局
Number of cured patients
时间窗: 3 months
Number of patients cured
Number of patients with treatment-related adverse events
时间窗: 4 weeks
MSC application related adverse events assessed by blood count, liver and function tests
次要结局
未报告次要终点