AzoospermiaPhase 1/2NCT02041910
Testicular Injection of Autologous Stem Cells for Treatment of Patients With Azoospermia
A Phase 1/2 study testing Stem Cells in people with Azoospermia, run by Hesham Saeed Elshaer at 1 site in Egypt.
Trial summary
Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia affects about 1% of the male population and may be seen in up to 20% of male infertility situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm production severely disturbed to absent. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Azoospermia
- What is being tested?
- Stem Cells
- 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
- Jan 2014to Mar 2015
- 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 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with non-obstructive Azoospermia
- Patients between 25 - 60 years old.
Who cannot join
- Patients with obstructive Azoospermia
- Men with previous surgery in testis
- Men with infectious genital diseases and anatomical abnormalities of the genital tract
- Those with major medical problems such as malignancy, hepatitis, etc.
- Chromosomal aberration (e.g. Y microdeleion, trisomy….)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
El-Rayadh Fertility Center
Al Mohandseen, Giza Governorate
Hesham El Shaer, MD, +201223130881, dr.heshamelshaer@hotmail.com
Prof. Dr. Hesham Elshaer, MD
About this study
Official title: Testicular Injection of Autologous Human Bone Marrow Derived Stem Cells for Treatment of Patients With Azoospermia
Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia affects about 1% of the male population and may be seen in up to 20% of male infertility situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm production severely disturbed to absent. FSH levels tend to be elevated (hypergonadotropic) as the feedback loop is interrupted. The condition is seen in 49-93% of men with Azoospermia. The purpose of this study is to assess the ability of bone marrow derived stem cells to differentiate into germ cells and their role in treatment of testicular Azoospermia
Read the detailed description
This study is an open-label investigation of the efficacy of injection autologous adult bone marrow derived stem cells into the somniferous tubules or interstitial spaces of male testis with Azospermia. Sixty men with Azoospermia will be recruited in this study after a written informed consent.
The diagnosis of Azoospermia will be established on the basis of two semen analysis evaluations done at separate occasions; this will be followed by detailed history taking, physical examination and investigations. History taking will include general health, sexual health, past fertility, libido, sexual activity and previous exposure to surgery, drugs, mumps infection and irradiation. Physical examination includes genital and local examination for detection of signs of Klinefelter syndrome, testicular atrophy, absence of vas. Investigations include serum FSH, LH, karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated (Low levels of LH and FSH with low or normal testosterone levels are indicative of pretesticular problems, while high levels of gonadotropins indicate testicular problems. However, often this distinction is not clear and the differentiation between obstructive versus non-obstructive Azoospermia may require a testicular biopsy).
Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one testis only and the other testis will be spared.
- Conditions
- Azoospermia
- Being tested
- Stem Cells
- Medical subject headings
- Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem CellsBiological
Also called MSCs
MSCs injection intratesticular
Stem CellsBiological
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 testis.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells | Experimental | 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 testis. Receives: Biological: Stem Cells |
| Stem Cells Injection | Experimental | Stem Cell Dose 3-5 Million Autologous MSCs Injected into testis. Receives: Biological: Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cases Improvement
Serum Hormonal Profile:
(elevation of testosterone levels, decreasing of FSH, LH and Prolactine Levels); Testicular Size (increased size); and Sexual Potency (increased sexual potency).
Measured: 12 Weeks
Secondary outcomes (1)
Cases Improvement
Testicular biopsy
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 posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AzoospermiaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hesham Saeed Elshaer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hesham Saeed Elshaer, El-Rayadh Fertility Centre
- Investigators
- Taimour Khalifa, MD, Principal investigator, Al-Azhar UniversitySayed Bakry, PhD, Study director, Al-Azhar UniversityHala Gabr, MD, Study chair, Cairo UniversityWael Abu El Khier, MD, Study chair, Military Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041910
- Sponsor's protocol ID
- NCT0550330
- Other IDs
- RFC0550330
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Injection of Autologous Human Bone Marrow Derived Stem Cells for Treatment of Patients With Azoospermia
- ClinicalTrials.gov ID
- NCT02041910
- Acronym / sponsor ID
- NCT0550330
- Conditions
- Azoospermia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hesham Saeed ElshaerUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 22 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.
Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia affects about 1% of the male population and may be seen in up to 20% of male infertility situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm production severely disturbed to absent. FSH levels tend to be elevated (hypergonadotropic) as the feedback loop is interrupted. The condition is seen in 49-93% of men with Azoospermia. The purpose of this study is to assess the ability of bone marrow derived stem cells to differentiate into germ cells and their role in treatment of testicular Azoospermia
Detailed description
This study is an open-label investigation of the efficacy of injection autologous adult bone marrow derived stem cells into the somniferous tubules or interstitial spaces of male testis with Azospermia. Sixty men with Azoospermia will be recruited in this study after a written informed consent.
The diagnosis of Azoospermia will be established on the basis of two semen analysis evaluations done at separate occasions; this will be followed by detailed history taking, physical examination and investigations. History taking will include general health, sexual health, past fertility, libido, sexual activity and previous exposure to surgery, drugs, mumps infection and irradiation. Physical examination includes genital and local examination for detection of signs of Klinefelter syndrome, testicular atrophy, absence of vas. Investigations include serum FSH, LH, karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated (Low levels of LH and FSH with low or normal testosterone levels are indicative of pretesticular problems, while high levels of gonadotropins indicate testicular problems. However, often this distinction is not clear and the differentiation between obstructive versus non-obstructive Azoospermia may require a testicular biopsy).
Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one testis only and the other testis will be spared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem Cells | Experimental | 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 testis. |
| Stem Cells Injection | Experimental | Biological: Stem CellsStem Cell Dose 3-5 Million Autologous MSCs Injected into testis. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with non-obstructive Azoospermia
- Patients between 25 - 60 years old.
Key exclusion criteria (5 listed)
- Patients with obstructive Azoospermia
- Men with previous surgery in testis
- Men with infectious genital diseases and anatomical abnormalities of the genital tract
- Those with major medical problems such as malignancy, hepatitis, etc.
- Chromosomal aberration (e.g. Y microdeleion, trisomy….)
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: MSCsMSCs injection intratesticular | Biological | Stem Cells |
| 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 testis. | Biological | Stem Cells Injection |
Primary outcome
Cases Improvement
Time frame: 12 Weeks
Serum Hormonal Profile: (elevation of testosterone levels, decreasing of FSH, LH and Prolactine Levels); Testicular Size (increased size); and Sexual Potency (increased sexual potency).
1 secondary outcome
Cases Improvement
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 22 Jan 2014.
Related trials for Azoospermia
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
RecruitingObservational study
Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
RecruitingPhase 1/2
Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.
Non-obstructive Azoospermia
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
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 Khalifa, MD principal investigator
Al-Azhar University
Sayed Bakry, PhD study director
Al-Azhar University
Hala Gabr, MD study chair
Cairo 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 Azoospermia, run by Hesham Saeed Elshaer 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 5 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 22 Jan 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 Hesham El Shaer, MD (+201223130881, dr.heshamelshaer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cases Improvement (time frame: 12 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 22 Jan 2014.