A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and Tolerability assessed by Adverse Events
研究概览
简要总结
This project will clarify the safety and effectiveness of human amniotic epithelial cells transplantation for the treatment of primary ovarian failure (POF) patients and provide a new therapeutic method for patients with infertility.
详细描述
POF is a defect characterized by the premature depletion of ovarian follicles. Patients with POF suffer from amenorrhea, infertility, low levels of estrogen, and high gonadotropin concentration before the age of 40. The early failure of ovarian function leads to lost fertility and increases risk of osteoporosis and cardiovascular disease, which has serious impact on the patient's physical, mental health and family stability. The etiology of POF is complex, and so far there has not been any effective treatment. Recent study showed that human amniotic epithelial cells (hAECs), also known as the birth waste, are newly discovered adult stem cells. The hAECs have the ability to repair nerve damage, myocardial injury, as well as liver damage. hAECs have low immunogenicity and no ethical restrictions. Therefore, hAECs are expected to become the new seed cells for regenerative medicine. Our previous study was the first to show that human amniotic epithelial cells have the ability to restore folliculogenesis in a mouse model with chemotherapy-induced premature ovarian failure. Our further studies demonstrated that hAECs either directly transdifferentiated into granulosa cells, or inhibited tumor necrosis factor-alpha-mediated granulosa cell apoptosis and reduced the inflammatory reaction in ovaries induced by chemotherapeutics, regulating VEGFA and its receptors to induce follicular growth related to paracrine activity. Therefore, it is necessary to start the clinical study of human amniotic epithelial cells transplantation in the POF disease which may offer a novel therapeutic strategy for improving the quality of life of POF patients.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 and<45 years old.
- •Female patients with documented diagnosis of POF: <40 years old, at least 4 months of amenorrhea not due to pregnancy, two FSH levels above 40 IU/L, at least one month apart.
- •Not in other trial within 3 months prior to the start of this trial.
- •Willing to participate in this trial and to give informed consent/assent before any procedures are performed in this trial.
排除标准
- •History of, or evidence of current malignancy within the past 5 years.
- •Severe functional impairment of vital organs.
- •Abnormal karyotype.
- •Coagulation disorders.
- •Severe pelvic adhesions.
- •Uncontrolled acute or chronic gynecologic inflammation.
- •Congenital adrenal cortical hyperplasia.
- •Cushing's syndrome.
- •Thyroid dysfunction.
- •Pituitary adenoma.
- •Pituitary amenorrhea or Hypothalamic amenorrhea.
- •Thrombophlebitis, venous thrombosis or artery thrombosis.
- •History of Oophorocystectomy.
- •Currently pregnant or breast-feeding.
- •Currently receiving other treatment that might affect the efficacy and safety of stem cells.
- •History of severe drug allergy.
- •Active infection detected by chest X-ray/CT.
- •HIV, TPAb positive.
- •Mental illness.
- •Currently participating in any other clinical trial that uses interventional drugs or examinations.
- •Patients that are deemed, by the investigator, inappropriate to participate in this trial.
结局指标
主要结局
Safety and Tolerability assessed by Adverse Events
时间窗: 150 days
Proportion of patients with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI，such as acute allergic reaction, ectopic mass formation related to treatment)
次要结局
- Change from baseline in bilateral ovarian volume(150 days)
- Change from baseline in Luteinizing hormone (LH), Estradiol (E2), Testosterone (T), Prolactin (PRL) , Anti-müllerian hormone (AMH) serum level(150 days)
- Change from baseline in Follicle-stimulating hormone (FSH) serum level(150 days)
- Change from baseline in number of antral follicles (AFC)(150 days)
- Menstruation resumption(150 days)
- Bone mineral density (BMD) measurements(150 days)
- Achievement of pregnancy(12 Months)
- Endometrial thickness(150 days)
研究者
Dongmei Lai
Principal Investigator
International Peace Maternity and Child Health Hospital