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

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02043743
• Other study ID #: NCT0221012014
• Secondary ID: RFC0221012014
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 10, 2014
• Last updated: January 21, 2014
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2014
• Source: El-Rayadh Fertility Centre
• Contact: Hesham Elshaer, MD
• Phone: +201223130881
• Email: dr.heshamelshaer[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and PopulationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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….).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Egypt	El-Rayadh Fertility Center	Giza

Sponsors (1)

Lead Sponsor	Collaborator
El-Rayadh Fertility Centre

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cases Improvement	Decline in serum FSH level. Rise in serum estrogen level Elevation in serum AMH level	48 Weeks	Yes
Secondary	Cases Improvement	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.	48 Weeks	Yes