Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Premature Ovarian Failure Clinical Trial

Official title:

Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02062931
• Other study ID #: NCT223101547
• Secondary ID: AzharU223101547
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 7, 2014
• Last updated: May 12, 2014
• Start date: March 2012
• Est. completion date: November 2016

Study information

• Verified date: May 2014
• Source: Al-Azhar University
• Contact: Yehia Wafa, MD
• Phone: +201223101547
• Email: yehiawafa[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEgypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Egypt	Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Sayed Bakry	Affiliated Hospital to Academy of Military Medical Sciences, Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

M. Edessy, Hala N. Hosni, Y. Wafa, S Bakry, Y.Shady and M.Kamel. Stem Cells Transplantation in Premature Ovarian Failure.World Journal of Medical Sciences 10 (1): 12-16, 2014

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Cases	Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.	48 Weeks	Yes
Secondary	Improvement of Cases	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.	48 Weeks	Yes