Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction of intrauterine scar area,the change of intrauterine adhesion
研究概览
简要总结
Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide clinical evidence for the treatment of uterine infertility
详细描述
Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is no effective treatment to the infertility caused by severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe intrauterine adhesions.Collagen is the main component of the extracellular matrix with good biocompatibility, and it has been approved for the reparation of skin and oral mucosa by State Food and Drug Administration. Bone marrow stem cells have been used in the clinical treatment of blood diseases, and achieved good results. In this study, collagen scaffold and autologous bone marrow stem cells are combined, and they showed good biological safety
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertility caused by serious intrauterine adhesions or endometrial dysplasia
- •Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia
- •Monitoring of endometrial cycle
- •Sign a consent form
- •Follow the test plan and follow-up process
排除标准
- •Abnormal chromosome karyotype
- •Congenital uterine malformations
- •Severe endometriosis
- •Severe adenomyosis
- •Contraindications to pregnancy
- •Contraindications to bone marrow collection
- •Contraindications to hormone replacement therapy
- •Medical history of pelvic tumors or receiving pelvic radiotherapy
- •Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period
结局指标
主要结局
Reduction of intrauterine scar area,the change of intrauterine adhesion
时间窗: up to 3 months
hysteroscope ,understanding improvement of uterine cavity form,the degree and nature of adhesion or the vanishment of intrauterine adhesion,and the reduction of scar and its area,comparing with pre-operation
次要结局
- The change of endometrial thickness(up to 2 months)
- menstrual blood volume The change of menstrual blood volume(baseline and 1 month)
研究者
Yali Hu
MD,PhD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School