Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMay 13, 2014
May 1, 2014
3.2 years
February 7, 2014
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of Cases
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
48 Weeks
Secondary Outcomes (1)
Improvement of Cases
48 Weeks
Study Arms (1)
Stem Cell Preparation and Injection
EXPERIMENTALStem Cell Preparation and Injection: 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 and suspended in platelets rich plasma (PRP) using GMP rules and finally injected into ovarian tissues and ligaments . Stem Cell Dose: 3-5 Million Autologous MSCs Injected into Ovarian tissue.
Interventions
Stem Cells 60 ml of bone marrow will aspirated using local anathesia and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared. Blood sample drawn from venous blood centrifuged and then platelets rich plasma (PRP) collected. The purified and collected stem cells suspended in platelets rich plasma (PRP) using GMP rules and finally injected into ovarian tissues and ligaments . Stem Cell Dose: 3-5 Million Autologous MSCs Injected into Ovarian tissue.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sayed Bakrylead
- Cairo Universitycollaborator
- Affiliated Hospital to Academy of Military Medical Sciencescollaborator
Study Sites (1)
Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)
Cairo, Cairo Governorate, Egypt
Related Publications (1)
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
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Edessy, MD
Al-Azhar University
- PRINCIPAL INVESTIGATOR
Yehia Wafa, MD
Al-Azhar University
- STUDY CHAIR
Hasan Tarabay, MD
Al-Azhar University
- STUDY CHAIR
Youssef Abu Shady, MD
Al-Azhar University
- STUDY CHAIR
Hala Hosni, MD
Cairo University
- STUDY DIRECTOR
Sayed Bakry, PhD
Al-Azhar University
- STUDY CHAIR
Wael Abu Elkhier, MD
Military Academy
- STUDY CHAIR
Hala Gabr, MD
Cairo University
- STUDY CHAIR
Medhat Kamel, MSc
Al-Azhar University
- STUDY CHAIR
Hamza El Tahan, BSc
Al-Azhar University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor - Consultant of Culturing and Isolation of Stem Cells
Study Record Dates
First Submitted
February 7, 2014
First Posted
February 14, 2014
Study Start
March 1, 2012
Primary Completion
May 1, 2015
Study Completion
November 1, 2016
Last Updated
May 13, 2014
Record last verified: 2014-05