Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
NCT ID: NCT02665520
Last Updated: 2016-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2015-10-31
2017-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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stem cells injection in penis
Treatment Injection of adipose derived cells into penis experimental;randomised
liposuction for retrieval of own stem cells from fat cells
controled arm
No interventions assigned to this group
Interventions
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liposuction for retrieval of own stem cells from fat cells
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
* Prior systemic chemotherapy, or radiotherapy to donor or recipient area
* Not in potentially active sexual relationship
* Age less than 40 or over 70
40 Years
70 Years
MALE
No
Sponsors
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King Saud University
OTHER
Elaj medical centers
OTHER
Responsible Party
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Mohamad Habous
Dr Mohamad Habous
Principal Investigators
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Saleh Binsaleh, MD
Role: STUDY_DIRECTOR
King Saud University
Locations
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Elaj medical group
Jeddah, Outside U.S./Canada, Saudi Arabia
kING SAUD UNIVERSITY
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Elaj stem cells 1
Identifier Type: -
Identifier Source: org_study_id
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