Premature Ovarian FailurePhase 1/2NCT02372474
"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
A Phase 1/2 study testing Stem cell in people with Premature Ovarian Failure, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- Stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Autoimmune diseases.
- Breast cancer, ovarian cancer.
- Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
- Those with major medical problems such as malignancy, hepatitis, etc.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.
Read the detailed description
Stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. They are self sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop in many different cell types in the body. 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. This work aimed to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) transplantation in women suffering from POF. Out of 112 high risk patients for POF, 10 cases were diagnosed as POF. The ten POF patients were scheduled for MSC transplantation at Al- Azhar University Hospitals. MSC preparation from the bone marrow of the iliac crest was laparoscopically injected in the ovaries. Endometrial fractional biopsy is histopathologically (HP) and Immunohistochemically (IH) stained and evaluated according to Edessy stem cells score (ESS) (1).
- Conditions
- Premature Ovarian Failure
- Being tested
- Stem cell
- Keywords
- POF, ESS, stem cell therapy
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cellBiological
Also called - Edessy Stem cell Score., - Laparoscopic stem cell transplantation., - Hormonal Analysis, - Ultrasonic evaluation
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).
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell therapy in POF | Experimental | POF cases were evaluated hormonally, HP and IH using ESS. Autologous MSC were prepared and laparoscopically transplanted. Receives: Biological: Stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 128 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edessy Mahmoud, Al-Azhar University
- Investigators
- Mahmoud Edessy, Professor, Principal investigator, Al-Azhar UniversityHala N Hosni, Professor, Study chair, Cairo UniversityYousef Shdy, MD, Study chair, Al-Azhar UniversitySyed Bkry, MD, Study chair, Al-Azhar UniversityMedhat Kamel, Msc, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372474
- Sponsor's protocol ID
- M Edessy
- Status last verified
- Feb 2015
- First submitted
- 12 Jan 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
- ClinicalTrials.gov ID
- NCT02372474
- Acronym / sponsor ID
- M Edessy
- Conditions
- Premature Ovarian Failure
- Keywords
- POF, ESS, stem cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.
Detailed description
Stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. They are self sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop in many different cell types in the body. 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. This work aimed to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) transplantation in women suffering from POF. Out of 112 high risk patients for POF, 10 cases were diagnosed as POF. The ten POF patients were scheduled for MSC transplantation at Al- Azhar University Hospitals. MSC preparation from the bone marrow of the iliac crest was laparoscopically injected in the ovaries. Endometrial fractional biopsy is histopathologically (HP) and Immunohistochemically (IH) stained and evaluated according to Edessy stem cells score (ESS) (1).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell therapy in POF | Experimental | Biological: Stem cellPOF cases were evaluated hormonally, HP and IH using ESS. Autologous MSC were prepared and laparoscopically transplanted. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Autoimmune diseases.
- Breast cancer, ovarian cancer.
- Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
- Those with major medical problems such as malignancy, hepatitis, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cellAlso: - Edessy Stem cell Score., - Laparoscopic stem cell transplantation., - Hormonal Analysis, - Ultrasonic evaluationOut 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). | Biological | Stem Cell therapy in POF |
Primary outcome
Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF.
Time frame: 128 weeks
Cases underwent sc transplantation were followed up for occurrence of menstruation and pregnancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Edessy, Professor principal investigator
Al-Azhar University
Hala N Hosni, Professor study chair
Cairo University
Yousef Shdy, MD study chair
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stem cell in people with Premature Ovarian Failure, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF. (time frame: 128 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.