Clinical Study of Minimally Invasive Implantation of Human Amniotic Epithelial Cells in the Treatment of Premature Ovarian Insufficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Changes of follicle stimulating hormone(FSH)
研究概览
简要总结
This project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.
详细描述
Premature ovarian insufficiency (POI) refers to women before the 40 years of age who suffer clinical manifestations of ovarian recession. Now, there is no exact and effective treatment to restore ovarian function. Human amniotic Epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics of embryonic stem cells, as well as a strong differentiation potential and plasticity. Experiments show that the fertility of mice is significantly improved after amniotic epithelial cells implantation. In order to further study the role of hAECs in POI treatment, this project will conduct minimally invasive implantation with hAECs in 20 cases of POI patients, and evaluate the changes of ovarian function and the safety of hAECs implantation. hAECs is prepared by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of POI, excluding genetic disease caused by patients; POI diagnostic criteria: Patients that <40 years of age, oligomenorrhea for 4 months,FSH> 25 IU/L.
- •Have fertility requirements;
- •Agree to sign the designed consent for the study.
排除标准
- •Breast cancer, ovarian cancer and other cancer/tumor;
- •Contraindications for pregnancy;
- •Coagulation disorder and other abnormal physical conditions.
结局指标
主要结局
Changes of follicle stimulating hormone(FSH)
时间窗: 1 year
Serum FSH level is evaluated once a month after treatment.
antral follicle count (AFC)
时间窗: 1 year
the number of primordial egg follicles within the ovary per menstrual cycle
次要结局
- estrogen 2(E2)(1 year)
- Anti Mullerian Hormone(AMH)(1 year)
- Menstrual situation(1 year)
- Luteinizing Hormone(LH)(1 year)
- Ovarian volume(1 year)