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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by El-Rayadh Fertility Centre
Sponsor:
Information provided by (Responsible Party):
El-Rayadh Fertility Centre
ClinicalTrials.gov Identifier:
NCT02043743
First received: January 10, 2014
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Premature Ovarian Failure
Biological: Biological: Stem Cells
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 Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure

Resource links provided by NLM:


Further study details as provided by El-Rayadh Fertility Centre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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….).
  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: NCT02043743

Contacts
Contact: Hesham Elshaer, MD +201223130881 dr.heshamelshaer@hotmail.com

Locations
Egypt
El-Rayadh Fertility Center Recruiting
Giza, Egypt
Contact: Hesham Elshaer, MD    +201223130881    dr.heshamelshaer@hotmail.com   
Sponsors and Collaborators
El-Rayadh Fertility Centre
Investigators
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
  More Information

No publications provided

Responsible Party: El-Rayadh Fertility Centre
ClinicalTrials.gov Identifier: NCT02043743     History of Changes
Other Study ID Numbers: NCT0221012014, RFC0221012014
Study First Received: January 10, 2014
Last Updated: January 21, 2014
Health Authority: Egypt: Ministry of Health and Population
United States: Food and Drug Administration

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 October 23, 2014