Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement of Cases
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Stem Cell Preparation and Injection
Stem Cell Preparation and Injection:
Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared and 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.
Intervention: Stem Cell Preparation and Injection (Biological)
Outcomes
Primary Outcomes
Improvement of Cases
Time Frame: 48 Weeks
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
Secondary Outcomes
- Improvement of Cases(48 Weeks)
Investigators
Sayed Bakry
Associate Professor - Consultant of Culturing and Isolation of Stem Cells
Al-Azhar University