Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure

NCT ID: NCT02043743

Last Updated: 2014-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-01-31

Brief Summary

Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism, and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer responding to circulating FSH by producing estrogen and developing fertile eggs) in women younger than 40 years. This condition occurs in approximately 1% of women and it has important physical and psychological consequences/impact in those patients.

The purpose of this study is to investigate the role of the transplantation of bone marrow derived stem cells into ovarian tissue for treatment of premature ovarian failure and to assess their ability to differentiate into germ cells.

Detailed Description

This study is an open-label investigation of the efficacy of injection of autologous adult bone marrow derived stem cells into the ovarian stroma of patients with premature ovarian failure. Sixty women with premature ovarian failure will be recruited in this study after a written informed consent. Diagnosis will be based mainly on history taking, physical examination and investigations. Laboratory investigations will include Serum follicle-stimulating hormone (FSH), serum estrogen measurement and serum AMH. The anterior pituitary secretes FSH and LH at high levels due to the dysfunction of the ovaries and consequent low estrogen levels. Typical FSH in POF patients is over 40 mlU/ml (post-menopausal range). Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by a gynecological surgeon through a standard surgical approach (transvaginal U/S guided approach). Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one ovary only and the other ovary will be spared.

Conditions

Premature Ovarian Failure

Study Design

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

Study Groups

Laboratory and Clinical

Biological: 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 using GMP rules and finally injected into rete testis.

Stem Cell Dose:

•3-5 Million Autologous MSCs Injected into Ovarian tissue.

Group Type: EXPERIMENTAL

Biological: Stem Cells

Intervention Type: BIOLOGICAL

Biological: 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 using GMP rules and finally 3-5 million MSCs injected into ovarian tissue.

Interventions

Biological: Stem Cells

Biological: 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 using GMP rules and finally 3-5 million MSCs injected into ovarian tissue.

Intervention Type: BIOLOGICAL

Other Intervention Names

Stem Cells Transplantation

Eligibility Criteria

Inclusion Criteria

• Patients with normal karyotype spontaneous premature ovarian failure.
• Patients between 18 - 40 years old.

Exclusion Criteria

• Patients with secondary ovarian failure (e.g. hypothalamic causes).
• Pregnancy and lactation.
• Autoimmune diseases.
• Those with major medical problems such as malignancy, hepatitis, etc.
• Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome….).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

El-Rayadh Fertility Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof.Dr. Hesham Elshaer, MD

Role: PRINCIPAL_INVESTIGATOR

El-Rayadh Fertility Center

Sayed Bakry, PhD

Role: STUDY_DIRECTOR

Al-Azhar University

Wael Abu El Khier, MD

Role: STUDY_CHAIR

Military Academy

Hala Gabr, MD

Role: STUDY_CHAIR

Cairo University

Locations

El-Rayadh Fertility Center

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hesham Elshaer, MD

Role: CONTACT

dr.heshamelshaer@hotmail.com

+201223130881

Facility Contacts

Hesham Elshaer, MD

Role: primary

dr.heshamelshaer@hotmail.com

+201223130881

Other Identifiers

RFC0221012014

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCT0221012014

Identifier Type: -

Identifier Source: org_study_id