Erectile DysfunctionNCT02414308
Management of Peyronie's Disease With Adipose Tissue Stem Cell
A study testing Adipose tissue stem cell injection in people with Erectile Dysfunction and Peyronie' Disease, run by Man Clinic for Andrology, Male Infertility and Sexual Dysfunction at 2 sites in Egypt.
Trial summary
Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Peyronie' Disease
- What is being tested?
- Adipose tissue stem cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2013to Jul 2016
- Phase
- Interventional
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- erectile dysfunction associated with Peyroni's diseas
Who cannot join
- nil
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Man clinic for andrology and male infertility
Cairo, Cairo Governorate, 33611
Khaled A Gadalla, MD, ABS, 20222725025, Khaledgadalla@gmail.com
- Recruiting
Man clinic
Cairo, 11366
Khaled A Gadalla, MD, ABS, 20222725025, Khaledgadalla@gmail.com
Khaled A Gadalla, MD, ABS
About this study
Official title: The Role of Adipose Tissue Stem Cell Injection Through Corpora Cavernosa and Intra Dorsal Penile Artery in Management of Erectile Dysfunction Associated With Peyronie's Disease
Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results We can start conservative treatment and then surgical treatment if fail but the outcome still not convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis We start to use stem cell in patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under Doppler device guidance
Read the detailed description
Peyronie's disease associated with erectile dysfunction nan be treated by different methods We start to treat such patients with adipose tissue stem cell Harvesting stem cell from adipose tissue and injected into corpora cavernosa and penile artery and we assess quality of erection through patient history and penile duplex and also assess plaque size and other symptoms related to Peyronie's disease
- Conditions
- Erectile Dysfunction, Peyronie' Disease
- Being tested
- Adipose tissue stem cell injection
- Keywords
- Erectile dysfunction, Peyronie's disease, stem cell
- Medical subject headings
- Erectile Dysfunction, Balanitis Xerotica Obliterans, Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue stem cell injectionDrug
Stem cell will be harvested through adipose tissue by liposuction and isolation occurred Injection will distribute through corpora cavernosa and dorsal penile artery
| Study group | Role | What they receive |
|---|---|---|
| Adipose tissue stem cell injection | Experimental | The stem cell will be harvested by liposuction and injection will be at corpora cavernosa and dorsal penile artery Receives: Drug: Adipose tissue stem cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual function questionnaire
Clinical history of patients before and after treatment Penile duplex study
Measured: 2-3 months
Secondary outcomes (1)
Penile plaque assessment
Clinical examination Patient history Penile duplex
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
- Investigators
- Khaled A Gadalla, MD, ABS, Principal investigator, Man clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414308
- Sponsor's protocol ID
- 003
- Status last verified
- Apr 2015
- First submitted
- 6 Jan 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Adipose Tissue Stem Cell Injection Through Corpora Cavernosa and Intra Dorsal Penile Artery in Management of Erectile Dysfunction Associated With Peyronie's Disease
- ClinicalTrials.gov ID
- NCT02414308
- Acronym / sponsor ID
- 003
- Conditions
- Erectile Dysfunction, Peyronie' Disease
- Keywords
- Erectile dysfunction, Peyronie's disease, stem cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Man Clinic for Andrology, Male Infertility and Sexual DysfunctionUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 10 Apr 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.
Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results We can start conservative treatment and then surgical treatment if fail but the outcome still not convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis We start to use stem cell in patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under Doppler device guidance
Detailed description
Peyronie's disease associated with erectile dysfunction nan be treated by different methods We start to treat such patients with adipose tissue stem cell Harvesting stem cell from adipose tissue and injected into corpora cavernosa and penile artery and we assess quality of erection through patient history and penile duplex and also assess plaque size and other symptoms related to Peyronie's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adipose tissue stem cell injection | Experimental | Drug: Adipose tissue stem cell injectionThe stem cell will be harvested by liposuction and injection will be at corpora cavernosa and dorsal penile artery |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- erectile dysfunction associated with Peyroni's diseas
Key exclusion criteria (1 listed)
- nil
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 |
|---|---|---|
| Adipose tissue stem cell injectionStem cell will be harvested through adipose tissue by liposuction and isolation occurred Injection will distribute through corpora cavernosa and dorsal penile artery | Drug | Adipose tissue stem cell injection |
Primary outcome
sexual function questionnaire
Time frame: 2-3 months
Clinical history of patients before and after treatment Penile duplex study
1 secondary outcome
Penile plaque assessment
Time frame: 2-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
Khaled A Gadalla, MD, ABS principal investigator
Man clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose tissue stem cell injection in people with Erectile Dysfunction and Peyronie' Disease, run by Man Clinic for Andrology, Male Infertility and Sexual Dysfunction at 2 sites 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 1 inclusion and 1 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Khaled A Gadalla, MD, ABS (20222725025, Khaledgadalla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual function questionnaire (time frame: 2-3 months). 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 10 Apr 2015.