Clinical Trial: Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Sayed Bakry

Current Primary Outcome: Improvement of Cases [ Time Frame: 48 Weeks ]

Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.


Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement of Cases [ Time Frame: 48 Weeks ]

Participants were followed up monthly(Every 4WKs) and Assessed by:

Hormonal Assessment. Clinical Assessment. Ultra Sound Assessment. Disappearance of Menopausal Symptoms. Pregnancy rate within 1 year. Miscarriage rate within one year of injection. Long term follow-up for any adverse effect, assessed for one year from injection.



Original Secondary Outcome: Same as current

Information By: Al-Azhar University

Dates:
Date Received: February 7, 2014
Date Started: March 2012
Date Completion: November 2016
Last Updated: May 12, 2014
Last Verified: May 2014