Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
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ClinicalTrials.gov Identifier: NCT02062931 |
Recruitment Status
: Unknown
Verified May 2014 by Sayed Bakry, Al-Azhar University.
Recruitment status was: Recruiting
First Posted
: February 14, 2014
Last Update Posted
: May 13, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Premature Ovarian Failure | Biological: Stem Cell Preparation and Injection | Phase 1 Phase 2 |
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 |

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

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062931
Contact: Yehia Wafa, MD | +201223101547 | yehiawafa@hotmail.com | |
Contact: Sayed Bakry, PhD | +201006609978 | sayed.bakry@yahoo.com |
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 |
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 |
Publications of Results:
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 Key Record Dates |
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 |