Clinical trial NCT02062931: Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
Official title: Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Premature Ovarian Failure
Keywords: Primary Infertility
Primary Amenorrhea
Sex Steroid Deficiency
Premature Ovarian Failure (POF)
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Affiliated Hospital to Academy of Military Medical Sciences
First posted: 2014-02-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement of Cases
timeFrame: 48 Weeks
Secondary outcomes:
measure: Improvement of Cases
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)
Study officials:
affiliation: Al-Azhar University
name: Mahmoud Edessy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Yehia Wafa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Hasan Tarabay, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Youssef Abu Shady, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hala Hosni, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Sayed Bakry, PhD
role: STUDY_DIRECTOR
affiliation: Military Academy
name: Wael Abu Elkhier, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hala Gabr, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Medhat Kamel, MSc
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Hamza El Tahan, BSc
role: STUDY_CHAIR
References:
citation: 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