"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF.
研究概览
简要总结
The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.
详细描述
Stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. They are self sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop in many different cell types in the body. Premature ovarian failure (POF) is the loss of ovarian function in women less than 40 years. It is associated with sex steroid deficiency, amenorrhea, infertility, and elevated serum gonadotropins. This work aimed to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) transplantation in women suffering from POF. Out of 112 high risk patients for POF, 10 cases were diagnosed as POF. The ten POF patients were scheduled for MSC transplantation at Al- Azhar University Hospitals. MSC preparation from the bone marrow of the iliac crest was laparoscopically injected in the ovaries. Endometrial fractional biopsy is histopathologically (HP) and Immunohistochemically (IH) stained and evaluated according to Edessy stem cells score (ESS) (1).
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
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menarche female less than 40 years old.
- •Normal karyotyping female.
- •Primary ovarian failure females
- •Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
- •Agree to sign the designed consent for the study.
排除标准
- •Autoimmune diseases.
- •Breast cancer, ovarian cancer.
- •Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
- •Those with major medical problems such as malignancy, hepatitis, etc.
结局指标
主要结局
Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF.
时间窗: 128 weeks
Cases underwent sc transplantation were followed up for occurrence of menstruation and pregnancy.
次要结局
未报告次要终点
研究者
Edessy Mahmoud
Professor
Al-Azhar University
