Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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:
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
History of Changes
  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:

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
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

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

No publications provided

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:
Menopause, Premature
Primary Ovarian Insufficiency
Adnexal Diseases
Endocrine System Diseases
 Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases

ClinicalTrials.gov processed this record on March 03, 2015