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临床试验/NCT02372474
NCT02372474已完成1 期

"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2012年3月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edessy Mahmoud

Professor

Al-Azhar University

研究点 (1)

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