NCT02062931

Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sayed Bakry · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Premature Ovarian Failure

Interventions

Type	Name	Description
BIOLOGICAL	Stem Cell Preparation and Injection	Stem Cells 60 ml of bone marrow will aspirated using local anathesia and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared. Blood sample drawn from venous blood centrifuged and then platelets rich plasma (PRP) collected. The purified and collected stem cells suspended in platelets rich plasma (PRP) using GMP rules and finally injected into ovarian tissues and ligaments . Stem Cell Dose: 3-5 Million Autologous MSCs Injected into Ovarian tissue.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-05-01
• Completion: 2016-11-01
• First posted: 2014-02-14
• Last updated: 2014-05-13

Locations

1 site across 1 country: Egypt