Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely
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 patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel
详细描述
During the implementation of the project, it is planned to develop a method for the treatment of men urinary incontinence caused by prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the 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 urinary incontinence in animals.
In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured and then transplanted back to the periurethral area by five point injection in rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in submucosal space MSCs (20*10^6 cells) will be mixed with collagen solution (3,5% w|w). Follow up patients monitoring will occur at 1，3，6 and 12 months after injection.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Urinary incontinence
- •absence of acute inflammatory manifestations in the genitourinary system
- •period after prostatectomy is at least 12 months
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