Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Premature Ovarian Failure	Biological: Stem Cell Preparation and Injection	Phase 1; Phase 2

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
Study Start Date :	March 2012
Estimated Primary Completion Date :	May 2015
Estimated Study Completion Date :	November 2016

Arms and Interventions

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Arm

Intervention/treatment

Experimental: 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.

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.

Outcome Measures

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Primary Outcome Measures :

1. Improvement of Cases [ Time Frame: 48 Weeks ]
   Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Yehia Wafa, MD	+201223101547	yehiawafa@hotmail.com
Contact: Sayed Bakry, PhD	+201006609978	sayed.bakry@yahoo.com

Locations

Egypt
Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)	Recruiting
Cairo, Egypt
Contact: Yehia Wafa, MD +201223101547 yehiawafa@hotmail.com
Contact: Mahmoud Edessy, MD +201005646785 dredessy@gmail.com

Sponsors and Collaborators

Sayed Bakry

Cairo University

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

Principal Investigator:	Mahmoud Edessy, MD	Al-Azhar University
Principal Investigator:	Yehia Wafa, MD	Al-Azhar University
Study Chair:	Hasan Tarabay, MD	Al-Azhar University
Study Chair:	Youssef Abu Shady, MD	Al-Azhar University
Study Chair:	Hala Hosni, MD	Cairo University
Study Director:	Sayed Bakry, PhD	Al-Azhar University
Study Chair:	Wael Abu Elkhier, MD	Military Academy
Study Chair:	Hala Gabr, MD	Cairo University
Study Chair:	Medhat Kamel, MSc	Al-Azhar University
Study Chair:	Hamza El Tahan, BSc	Al-Azhar University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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

Responsible Party:	Sayed Bakry, Associate Professor - Consultant of Culturing and Isolation of Stem Cells, Al-Azhar University
ClinicalTrials.gov Identifier:	NCT02062931 History of Changes
Other Study ID Numbers:	NCT223101547; AzharU223101547 ( Registry Identifier: AzharU223101547 )
First Posted:	February 14, 2014
Last Update Posted:	May 13, 2014
Last Verified:	May 2014

Keywords provided by Sayed Bakry, Al-Azhar University:

Primary Infertility; Primary Amenorrhea; Sex Steroid Deficiency; Premature Ovarian Failure (POF)

Additional relevant MeSH terms:

Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications	Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Gonadal Disorders; Endocrine System Diseases