Male InfertilityPhase 1/2NCT02025270
MSCs For Treatment of Azoospermic Patients
A Phase 1/2 study testing Stem Cells in people with Male Infertility, run by Al-Azhar University at 1 site in Egypt.
Trial summary
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2012to 20 Dec 2022
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- All Non obstructive Azoospermic Patients.
- Azoospermic Patients due to Administration of Chemo/Radiotherapy.
Who cannot join
- Patients with Testicular Cancer.
- Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.
Read the detailed description
Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.
- Conditions
- Male Infertility
- Being tested
- Stem Cells
- Keywords
- Azoospermia, Spermatogonial Arrest, Maturation Arrest.
- Medical subject headings
- Infertility, Male, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem CellsBiological
Also called Stem Cell Dose, 3-5 Million Autologous MSCs Injected into rete testis.
60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory and Clinical | Other | 60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis. Receives: Biological: Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cases Improvement
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
Measured: One Year (12-Month)
Secondary outcomes (1)
All Cases Fertility Improvement
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.
Measured: One Year (12-Month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study start15 Oct 2012
- Primary completion15 Oct 2016
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Sayed Bakry, Al-Azhar University
- Investigators
- Taimour M Khalifa, MD Professor, Principal investigator, Al-Azhar UniversitySayed Bakry, PhD, Study director, Al-Azhar UniversitySaad Moneer, MSc, Study chair, Al-Azhar UniversityAhmed Kadeh, MSc, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025270
- Sponsor's protocol ID
- AZH010066099
- Other IDs
- Azhar23052011
- Status last verified
- Feb 2023
- First submitted
- 13 Dec 2013
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients
- ClinicalTrials.gov ID
- NCT02025270
- Acronym / sponsor ID
- AZH010066099
- Conditions
- Male Infertility
- Keywords
- Azoospermia, Spermatogonial Arrest, Maturation Arrest.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Oct 2012 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 1 Jan 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.
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.
Detailed description
Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory and Clinical | Other | Biological: Stem Cells60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All Non obstructive Azoospermic Patients.
- Azoospermic Patients due to Administration of Chemo/Radiotherapy.
Key exclusion criteria (2 listed)
- Patients with Testicular Cancer.
- Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
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 CellsAlso: Stem Cell Dose, 3-5 Million Autologous MSCs Injected into rete testis.60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis. | Biological | Laboratory and Clinical |
Primary outcome
All Cases Improvement
Time frame: One Year (12-Month)
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
1 secondary outcome
All Cases Fertility Improvement
Time frame: One Year (12-Month)
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 1 Mar 2023.
- Individual participant dataSharing planned: Yes
Related trials for Male Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
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Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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Sperm, Exposure and Endocrine Disruptors
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RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
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.
Taimour M Khalifa, MD Professor principal investigator
Al-Azhar University
Sayed Bakry, PhD study director
Al-Azhar University
Saad Moneer, MSc 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 Cells in people with Male Infertility, 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 2 inclusion and 2 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 1 Mar 2023. 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?
All Cases Improvement (time frame: One Year (12-Month)). 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 1 Mar 2023.