Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)
试验速览
- 阶段
- 1 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Number of mature follicle
研究概览
简要总结
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been previously documented. Herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from POI.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with primary ovarian insufficiency;
- •Women between 20 and 40 years;
- •Have fertility requirements, husband has sperm;
- •Willing to sign the Informed Consent Form.
排除标准
- •Primary amenorrhea;
- •Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
- •Thyroid dysfunction;
- •Severe endometriosis;
- •Contraindications for pregnancy;
- •Prior personal history of ovarian cancer;
- •Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
- •History of serious drug allergy or allergic constitution;
- •Autoimmune disease, history of severe familial genetic disease;
- •HIV+, hepatitis B, C;
研究组 & 干预措施
Control group
Hormone replacement therapy, placebo transplantation.
干预措施: Placebo transplantation (Biological)
Experimental group
Hormone replacement therapy,HUC-MSCs transplantation.
干预措施: HUC-MSCs transplantation (Biological)
结局指标
主要结局
Number of mature follicle
时间窗: Up to 4 months
The number of mature follicles developing was recorded by transvaginal ultrasound scan
次要结局
- Anti-Mullerian hormone (AMH) serum level(Up to 4 months)
- Follicle-stimulating hormone (FSH) serum level(Up to 4 months)
- Estradiol (E2) serum level(Up to 4 months)
- Number of antral follicle development(Up to 4 months)
- Ovarian volume(Up to 4 months)
- Pregnancy rate(Up to 12 months)
研究者
Hongmei Wang
Professor
Chinese Academy of Sciences