Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in Women With Primary Ovarian Insufficiency (POI)
试验速览
- 阶段
- 1 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Temperature
研究概览
简要总结
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.
详细描述
The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Under 40 years of age;
- •Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months;
- •FSH (Follicle-Stimulating Hormone) > 25 IU/mL;
- •Bilateral ovaries are visible by ultrasound;
- •Have fertility requirement, husband has sperms;
- •Willing to sign the Informed Consent Form.
排除标准
- •Primary amenorrhea;
- •History of serious drug allergy or allergic constitution;
- •Thrombophlebitis and thromboembolia, past and present;
- •Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease
- •Autoimmune disease, history of severe familial genetic disease, etc.
- •Anatomical abnormality of reproductive system;
- •Contraindications for pregnancy;
- •Spouse azoospermia;
- •HIV+, hepatitis B, C;
- •Thyroid dysfunction;
- •History of previous malignant or ovarian tumors, history of ovarian therapy;
- •Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
- •During pregnancy or lactation;
- •Alcohol or other substance abuse;
- •Mental disease, communicate obstruction;
- •Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
- •Attending doctor consider inappropriate to take part in.
结局指标
主要结局
Temperature
时间窗: 0-24 weeks
Body temperature of the participants will be measured fortnightly after injection.
Pulse
时间窗: 0-24 weeks
Pulse of the participants will be measured fortnightly after injection.
Breaths per minute
时间窗: 0-24 weeks
Breathing rate of the participants will be measured fortnightly after injection.
Blood pressure
时间窗: 0-24 weeks
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
次要结局
- Estradiol (E2) serum level(0-24 weeks)
- Anti-Mullerian hormone (AMH) serum level(0-24 weeks)
- Ovarian volume(0-24 weeks)
- Number of antral follicle(0-24 weeks)
- Follicle-stimulating hormone (FSH) serum level(0-24 weeks)
研究者
Hongmei Wang
Professor
Chinese Academy of Sciences