Erectile DysfunctionPhase 2NCT02665520
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
A Phase 2 study testing liposuction for retrieval of own stem cells from fat cells in people with Erectile Dysfunction, run by Elaj medical centers at 2 sites in Saudi Arabia.
Trial summary
Autologous Fat Derived Stem Cell treatment of ED. To assess safety and primary efficacy of stem cell infusion in refractory ED. To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- liposuction for retrieval of own stem cells from fat cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Oct 2015to May 2017
- Phase
- Phase 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male 40 years old and older suffering from moderate to sever erectile dysfunction -
Who cannot join
- Inability to give informed consent or attend follow up
- Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease
- Viral disease from infectivity viewpoint
- Major penile fibrosis or severe Peyronie's disease
- Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)
- Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI)
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- Prior systemic chemotherapy, or radiotherapy to donor or recipient area
- Not in potentially active sexual relationship
- Age less than 40 or over 70
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Elaj medical group
Jeddah, Outside U.S./Canada, 21463
Mohamad Habous, +966599950131, drmhabos@hotmail.com
Saleh Binsaleh, MD
- Recruiting
kING SAUD UNIVERSITY
Riyadh
Saleh Binsaleh, MD, +966502100034, surgon@hotmail.com
About this study
Official title: Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction
Autologous Fat Derived Stem Cell treatment of ED.
To assess safety and primary efficacy of stem cell infusion in refractory ED.
To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- liposuction for retrieval of own stem cells from fat cells
- Keywords
- stem cells injections, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposuction for retrieval of own stem cells from fat cellsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| stem cells injection in penis | Active comparator | Treatment Injection of adipose derived cells into penis experimental;randomised Receives: Procedure: liposuction for retrieval of own stem cells from fat cells |
| controled arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events that occur during or after the procedure to measure safety and tolerability
to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elaj medical centers
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University
- Responsible party
- Principal investigator, Mohamad Habous, Elaj medical centers
- Investigators
- Saleh Binsaleh, MD, Study director, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665520
- Sponsor's protocol ID
- Elaj stem cells 1
- Status last verified
- Jan 2016
- First submitted
- 9 Mar 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02665520
- Acronym / sponsor ID
- Elaj stem cells 1
- Conditions
- Erectile Dysfunction
- Keywords
- stem cells injections, erectile dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Elaj medical centersUniversity, hospital or other
- Collaborators
- King Saud University
- Study start
- Oct 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 27 Jan 2016 (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.
Autologous Fat Derived Stem Cell treatment of ED.
To assess safety and primary efficacy of stem cell infusion in refractory ED.
To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stem cells injection in penis | Active comparator | Procedure: liposuction for retrieval of own stem cells from fat cellsTreatment Injection of adipose derived cells into penis experimental;randomised |
| controled arm | No intervention | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male 40 years old and older suffering from moderate to sever erectile dysfunction -
Key exclusion criteria (9 listed)
- Inability to give informed consent or attend follow up
- Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease
- Viral disease from infectivity viewpoint
- Major penile fibrosis or severe Peyronie's disease
- Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)
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 |
|---|---|---|
| liposuction for retrieval of own stem cells from fat cells | Procedure or surgery | stem cells injection in penis |
Primary outcome
Adverse Events that occur during or after the procedure to measure safety and tolerability
Time frame: 1 year
to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
Saleh Binsaleh, MD study director
King Saud University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liposuction for retrieval of own stem cells from fat cells in people with Erectile Dysfunction, run by Elaj medical centers at 2 sites in Saudi Arabia.
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 9 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 27 Jan 2016. 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 Saudi Arabia. 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 phase mean?
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 MOHAMAD HABOUS, M.D;FEBU (+966599950131, drmhabos@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events that occur during or after the procedure to measure safety and tolerability (time frame: 1 year). 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 27 Jan 2016.