Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure
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.
Premature Ovarian Failure
Biological: Biological: Stem Cells
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure|
- Cases Improvement [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]Decline in serum FSH level. Rise in serum estrogen level Elevation in serum AMH level
- Cases Improvement [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]Disappearance of menopausal symptoms e.g. hot flashes Rise in serum AMH level. 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.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Biological: 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.
Other Name: Stem Cells Transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02043743
|Contact: Hesham Elshaer, MDfirstname.lastname@example.org|
|El-Rayadh Fertility Center||Recruiting|
|Contact: Hesham Elshaer, MD +201223130881 email@example.com|
|Principal Investigator:||Prof.Dr. Hesham Elshaer, MD||El-Rayadh Fertility Center|
|Study Director:||Sayed Bakry, PhD||Al-Azhar University|
|Study Chair:||Wael Abu El Khier, MD||Military Academy|
|Study Chair:||Hala Gabr, MD||Cairo University|