Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Menstrual changes
研究概览
简要总结
Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.
详细描述
Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of function of the ovaries before age 40, which has the features of menstrual disorder with high gonadotropic hormone and low estrogen. The morbidity of POI is about 0.1% among woman before 40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary amenorrhea. Recent years research shows different sources of stem cell could be used to POI, and with effective results.
Above all, this experiment designed to as a single center, random, and control experiment. treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet diagnostic criteria of European Society of Human Reproduction and Embryology
- •No hormonotherapy and chinese traditional medicine within 3 months;
- •Understand and sign informed consent.
排除标准
- •Patient with congenital adrenocortical hyperplasia;
- •Patient with Cushing syndrome;
- •Patient with Thyroid dysfunction;
- •Patient with hyperprolactinemia;
- •Patient with pituitary amenorrhea or hypothalamic amenorrhea;
- •Patient with HIV, hepatitis;
- •Gene defect (eg. Turner syndrome, fragile X syndrome)
- •Serious drug allergy history;
- •Suffering from thrombophlebitis, thromboembolism including venous thrombosis and arterial thrombosis;
- •History of treatment of ovarian cysts or ovarian surgery
- •With high tumor marker;
- •Pregnant or lactating
- •Receive other treatments that may affect the efficacy and safety of stem cells;
- •Do not understand or without sign informed consent;
- •The attending physician believes that it is not suitable for participating in this trial
研究组 & 干预措施
Low dose group
Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml
干预措施: hucMSCs (Biological)
High dose group
Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml
干预措施: hucMSCs (Biological)
Medium dose group
Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml
干预措施: hucMSCs (Biological)
结局指标
主要结局
Menstrual changes
时间窗: 270 days
Observe the change of patients with irregular menstrual cycle
次要结局
- Kupperman score(270 days)
- Follicular development(270 days)
- hormone level(270 days)