Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT02665520
- Lead Sponsor
- Elaj medical centers
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 30
- Male 40 years old and older suffering from moderate to sever erectile dysfunction -
- 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)
- Prior systemic chemotherapy, or radiotherapy to donor or recipient area
- Not in potentially active sexual relationship
- Age less than 40 or over 70
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Adverse Events that occur during or after the procedure to measure safety and tolerability 1 year to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (2)
Elaj medical group
🇸🇦Jedda, Outside U.S./Canada, Saudi Arabia
kING SAUD UNIVERSITY
🇸🇦Riyadh, Saudi Arabia
Elaj medical group🇸🇦Jedda, Outside U.S./Canada, Saudi ArabiaMohamad HabousContact+966599950131drmhabos@hotmail.comSaleh Binsaleh, MDPrincipal Investigator