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临床试验/NCT02779374
NCT02779374终止不适用

Autologous Bone Marrow Transplantation for Treatment of Premature Ovarian Insufficiency

South Valley University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
menses

研究概览

简要总结

Currently, There is no treatment for Premature ovarian insufficiency (POI). Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are able to regenerate the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.

Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency.

Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.

详细描述

Premature ovarian insufficiency (POI) has no curative treatment until now. It was noticed that some cases of POI to recover spontaneously. Furthermore, the concept of fixed prenatal pool of oogonia has been challenged and postnatal neo-oogenesis is currently proved.

Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal insufficiency. Data from animal studies showed that stimulation of these stem cells result in regeneration of the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.

Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency. These studies have been followed by researches on human being. Human studies included the use of stem cells from different sites including BM, adipose tissue, and umbilical cord.

Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Although studies proved that these newly developed oocytes to be genetically traced to the recipient; some other studies showed that the newly developed oocytes originate from the donor BM. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Use of autologous BMT also avoids the need for chemotherapy for conditioning and other related complications associated with allogeneic BMT. Human studies mostly used the ovarian injection of the BM. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.

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
16 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with POI: For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice >4 weeks apart).

排除标准

  • Abnormal karyotype
  • Previous pelvic or abdominal radiotherapy
  • Previous surgical management of ovarian pathology
  • Chronic disease: renal, liver, cardiac, malignancy

结局指标

主要结局

menses

时间窗: 6 months

return of menses in a woman with previous ameneorrhea of at least 4 months before recruitment and during the 6 months of the pretest period

次要结局

  • Pregnancy(12 months)
  • FSH(12 months)
  • Antimullarian hormone (AMH)(12 months)
  • follicular activity(12 months)
  • Endometrial thickness(12 months)

研究者

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

Mohammad Abdel-Rahman Mohammad Ahmed

Doctor

South Valley University

研究点 (1)

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