Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

NCT ID: NCT02062931

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-11-30

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.

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.

Conditions

Premature Ovarian Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stem Cell Preparation and Injection

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: collaborator

Sayed Bakry

OTHER

Sponsor Role: lead

Responsible Party

Sayed Bakry

Associate Professor - Consultant of Culturing and Isolation of Stem Cells

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mahmoud Edessy, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Yehia Wafa, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Hasan Tarabay, MD

Role: STUDY_CHAIR

Al-Azhar University

Youssef Abu Shady, MD

Role: STUDY_CHAIR

Al-Azhar University

Hala Hosni, MD

Role: STUDY_CHAIR

Cairo University

Sayed Bakry, PhD

Role: STUDY_DIRECTOR

Al-Azhar University

Wael Abu Elkhier, MD

Role: STUDY_CHAIR

Military Academy

Hala Gabr, MD

Role: STUDY_CHAIR

Cairo University

Medhat Kamel, MSc

Role: STUDY_CHAIR

Al-Azhar University

Hamza El Tahan, BSc

Role: STUDY_CHAIR

Al-Azhar University

Locations

Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yehia Wafa, MD

Role: CONTACT

yehiawafa@hotmail.com

+201223101547

Sayed Bakry, PhD

Role: CONTACT

sayed.bakry@yahoo.com

+201006609978

Facility Contacts

Yehia Wafa, MD

Role: primary

yehiawafa@hotmail.com

+201223101547

Mahmoud Edessy, MD

Role: backup

dredessy@gmail.com

+201005646785

References

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

Reference Type: RESULT

Other Identifiers

AzharU223101547

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCT223101547

Identifier Type: -

Identifier Source: org_study_id