Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement of Cases
研究概览
简要总结
Stem cells (SC) are the foundation cells for every organ, tissue and cell in the body. They are undifferentiated "blank" cells that do not yet have a specific function. Under proper conditions, they begin to develop into specialized tissue and organs. They are self-sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop into many different cell types in the body. They serves as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person is still alive. 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. POF occurs in 1 % of women. In majority of cases the underlying cause is not identified. Management essentially involves hormone replacement and infertility treatment. This work aimed to evaluate the therapeutic potential of Autologous MSC transplantation in women suffering from Premature Ovarian Failure.
详细描述
Sample of 60 ml is aspirated from the bone marrow of the iliac crest and prepared in the lab and injected in the ovaries through laparoscopy. Endometrial fractional biopsy was taken, stained with H&E stain and by IH staining by stem cell marker OCT4. Immunohistochemical expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). Participants were followed up monthly for a period of six months by hormonal (FSH, LH and E2), clinical (resuming menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell marker OCT4 of the endometrial biopsy (stem cell positivity according to ESS) outcome.
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.
- •Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
- •Female with normal karyotyping.
- •Agree to sign the designed consent for the study.
排除标准
- •Pregnancy and lactation.
- •Autoimmune diseases.
- •Breast cancer, ovarian cancer.
- •Female with abnormal karyotyping (e.g. turner syndrome, fragile X syndrome....).
- •Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
- •Patients with secondary ovarian failure (e.g. hypothalamic causes)
- •Those with major medical problems such as malignancy, hepatitis, etc.
结局指标
主要结局
Improvement of Cases
时间窗: 48 Weeks
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
次要结局
- Improvement of Cases(48 Weeks)
研究者
Sayed Bakry
Associate Professor - Consultant of Culturing and Isolation of Stem Cells
Al-Azhar University