Clinical Study of the Treatment of Infertility Caused by Recurrent Intrauterine Adhesions by Collagen Scaffold Loaded With Umbilical Cord -Derived Mesenchymal Stem Cells (UC-MSCs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
Study of the treatment of infertility caused by recurrent intrauterine adhesions (IUA) by collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) to provide clinical evidence of safety and effectiveness 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 limited treatment to the infertility caused by severe IUA especially recurrent IUA after adhesiolysis which hinders embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe recurrent intrauterine adhesions. Collagen is the main component of the extracellular matrix with good biocompatibility, UC-MSCs have been used in the clinical treatment of diseases, and achieved good results. In this study, collagen scaffold and umbilical cord blood-derived mesenchymal 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Secondary infertility or failure of embryo transfer caused by recurrent intrauterine adhesions who desired to be pregnant
- •Hysteroscopy examination confirmed intrauterine adhesions
- •Sign a consent form
- •Follow the test plan and follow-up process
排除标准
- •have hysteroscopic contraindications
- •Chromosome karyotype abnormalities
- •Congenital uterine malformations
- •Severe adenomyosis
- •Contraindications to estradiol treatment
- •Medical history of pelvic tumors or receiving pelvic radiotherapy
研究组 & 干预措施
UC-MSCs therapy
transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by recurrent intrauterine adhesions
干预措施: UC-MSCs therapy (Procedure)
结局指标
主要结局
live birth rate
时间窗: 30 months
A baby born alive after 20 weeks gestation was classified as a live birth.
次要结局
- Reduction of intrauterine adhesion(3 months post-surgery)
- The change of endometrial thickness(up to 3 months)
- ongoing pregnant rate(30 months)
研究者
Yali Hu
MD,PhD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School