Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells
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 patients with treatment-related adverse events
研究概览
简要总结
Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future
详细描述
The aim of the project is to develop a biomedical cell product based on autologous adipose tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective treatment and prevention of scarring and adhesions in the uterus acquired as a result of cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes; to conduct the clinical trials of the biomedical cell product in the treatment of uterus scarring and infertility in women.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •chronic endometritis
- •postoperative uterus scars
- •uterine synechia
- •fallopian tube obstruction
- •absence of acute inflammation in the uterus
排除标准
- •Patients with genetic diseases of muscle and connective tissue;
- •Patients with malformations of the uterus;
- •Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;
- •mental disorders;
- •Drug or alcohol addiction;
- •Benign tumors of uterus and appendages;
- •Hypersensitivity to any component of the studied biomedical cell product.
结局指标
主要结局
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
Number of cured patients
时间窗: 6 months
Number of patients cured
次要结局
未报告次要终点