Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02665520|
Recruitment Status : Unknown
Verified January 2016 by Mohamad Habous, Elaj medical centers.
Recruitment status was: Recruiting
First Posted : January 27, 2016
Last Update Posted : January 27, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Procedure: liposuction for retrieval of own stem cells from fat cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||May 2017|
Active Comparator: stem cells injection in penis
Treatment Injection of adipose derived cells into penis experimental;randomised
Procedure: liposuction for retrieval of own stem cells from fat cells
|No Intervention: controled arm|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665520
|Contact: MOHAMAD HABOUS, M.D;FEBUfirstname.lastname@example.org|
|Contact: Saleh Binsaleh, MDemail@example.com|
|Elaj medical group||Recruiting|
|Jedda, Outside U.S./Canada, Saudi Arabia, 21463|
|Contact: Mohamad Habous +966599950131 firstname.lastname@example.org|
|Principal Investigator: Saleh Binsaleh, MD|
|kING SAUD UNIVERSITY||Recruiting|
|Riyadh, Saudi Arabia|
|Contact: Saleh Binsaleh, MD +966502100034 email@example.com|
|Study Director:||Saleh Binsaleh, MD||King Saud University|