Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2014 by Al-Azhar University
Sponsor:
Sayed Bakry
Collaborators:
Cairo University
Affiliated Hospital to Academy of Military Medical Sciences
Information provided by (Responsible Party):
Sayed Bakry, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT02062931
First received: February 7, 2014
Last updated: May 12, 2014
Last verified: May 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Premature Ovarian Failure |
Biological: Stem Cell Preparation and Injection |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure |
Resource links provided by NLM:
Genetics Home Reference related topics:
Turner syndrome
MedlinePlus related topics:
Premature Ovarian Failure
U.S. FDA Resources
Further study details as provided by Al-Azhar University:
Primary Outcome Measures:
- Improvement of Cases [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
Secondary Outcome Measures:
- Improvement of Cases [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
| Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02062931
Please refer to this study by its ClinicalTrials.gov identifier: NCT02062931
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
Publications:
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 |
| Study First Received: | February 7, 2014 |
| Last Updated: | May 12, 2014 |
| Health Authority: | United States: Institutional Review Board Egypt: Ministry of Higher Education |
Keywords provided by Al-Azhar University:
|
Primary Infertility Primary Amenorrhea Sex Steroid Deficiency Premature Ovarian Failure (POF) |
Additional relevant MeSH terms:
|
Primary Ovarian Insufficiency Premature Birth Menopause, Premature Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016