"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
1 other identifier
interventional
112
1 country
1
Brief Summary
The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.
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
Typical duration 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
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedFebruary 26, 2015
February 1, 2015
2.8 years
January 12, 2015
February 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF.
Cases underwent sc transplantation were followed up for occurrence of menstruation and pregnancy.
128 weeks
Study Arms (1)
Stem Cell therapy in POF
EXPERIMENTALPOF cases were evaluated hormonally, HP and IH using ESS. Autologous MSC were prepared and laparoscopically transplanted.
Interventions
Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H\&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).
Eligibility Criteria
You may qualify if:
- Post-menarche female less than 40 years old.
- Normal karyotyping female.
- Primary ovarian failure females
- Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
- Agree to sign the designed consent for the study.
You may not qualify if:
- Autoimmune diseases.
- Breast cancer, ovarian cancer.
- Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
- Those with major medical problems such as malignancy, hepatitis, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al Azhar University
Cairo, Cairo Governorate, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Edessy, Professor
Al-Azhar University
- STUDY CHAIR
Hala N Hosni, Professor
Cairo University
- STUDY CHAIR
Yousef Shdy, MD
Al-Azhar University
- STUDY CHAIR
Syed Bkry, MD
Al-Azhar University
- STUDY CHAIR
Medhat Kamel, Msc
Al-Azhar University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 12, 2015
First Posted
February 26, 2015
Study Start
March 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 26, 2015
Record last verified: 2015-02