Premature Ovarian FailurePhase 1/2NCT02062931
Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
A Phase 1/2 study testing Stem Cell Preparation and Injection in people with Premature Ovarian Failure, run by Sayed Bakry at 1 site in Egypt.
Trial 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. 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 Preparation and Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Nov 2016
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University hospitals and Al Azhar Regenerative Medicine International Center (ARMIC)
Cairo, Cairo Governorate
Yehia Wafa, MD, +201223101547, yehiawafa@hotmail.com
Mahmoud Edessy, MD, +201005646785, dredessy@gmail.com
About this study
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.
Read the 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.
- Conditions
- Premature Ovarian Failure
- Being tested
- Stem Cell Preparation and Injection
- Keywords
- Primary Infertility, Primary Amenorrhea, Sex Steroid Deficiency, Premature Ovarian Failure (POF)
- 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 Cell Preparation and InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Preparation and Injection | Experimental | Stem 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. Receives: Biological: Stem Cell Preparation and Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Cases
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
Measured: 48 Weeks
Secondary outcomes (1)
Improvement of Cases
Participants were followed up monthly(Every 4WKs) and Assessed by:
Hormonal Assessment. Clinical Assessment. Ultra Sound Assessment. Disappearance of Menopausal Symptoms. 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.
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startMar 2012
- Primary completionMay 2015 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sayed Bakry
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Affiliated Hospital to Academy of Military Medical Sciences
- Responsible party
- Sponsor-investigator, Sayed Bakry, Al-Azhar University
- Investigators
- Mahmoud Edessy, MD, Principal investigator, Al-Azhar UniversityYehia Wafa, MD, Principal investigator, Al-Azhar UniversityHasan Tarabay, MD, Study chair, Al-Azhar UniversityYoussef Abu Shady, MD, Study chair, Al-Azhar UniversityHala Hosni, MD, Study chair, Cairo UniversitySayed Bakry, PhD, Study director, Al-Azhar UniversityWael Abu Elkhier, MD, Study chair, Military AcademyHala Gabr, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062931
- Sponsor's protocol ID
- NCT223101547
- Other IDs
- AzharU223101547
- Status last verified
- May 2014
- First submitted
- 7 Feb 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
- ClinicalTrials.gov ID
- NCT02062931
- Acronym / sponsor ID
- NCT223101547
- Conditions
- Premature Ovarian Failure
- Keywords
- Primary Infertility, Primary Amenorrhea, Sex Steroid Deficiency, Premature Ovarian Failure (POF)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sayed BakryUniversity, hospital or other
- Collaborators
- Cairo University, Affiliated Hospital to Academy of Military Medical Sciences
- Study start
- Mar 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 14 Feb 2014 (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.
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.
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 Preparation and Injection | Experimental | Biological: Stem Cell Preparation and InjectionStem 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 Cell Preparation and InjectionStem 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. | Biological | Stem Cell Preparation and Injection |
Primary outcome
Improvement of Cases
Time frame: 48 Weeks
Decrease in serum FSH level. Elevation in serum estrogen level. Elevation in serum AMH level.
1 secondary outcome
Improvement of Cases
Time frame: 48 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Results publicationM. 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
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Oral GDC-0077 in Premature Ovarian Insufficiency
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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, MD principal investigator
Al-Azhar University
Yehia Wafa, MD principal investigator
Al-Azhar University
Hasan Tarabay, 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 Preparation and Injection in people with Premature Ovarian Failure, run by Sayed Bakry 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehia Wafa, MD (+201223101547, yehiawafa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Cases (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062931, which also lists 1 linked publication.
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 13 May 2014.