Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
King Saud University
Information provided by (Responsible Party):
Mohamad Habous, 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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Procedure: liposuction for retrieval of own stem cells from fat cells Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male 40 years old and older suffering from moderate to sever erectile dysfunction -

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: MOHAMAD HABOUS, M.D;FEBU +966599950131 drmhabos@hotmail.com
Contact: Saleh Binsaleh, MD +966502100034 surgon@hotmail.com

Locations
Layout table for location information
Saudi Arabia
Elaj medical group Recruiting
Jedda, Outside U.S./Canada, Saudi Arabia, 21463
Contact: Mohamad Habous    +966599950131    drmhabos@hotmail.com   
Principal Investigator: Saleh Binsaleh, MD         
kING SAUD UNIVERSITY Recruiting
Riyadh, Saudi Arabia
Contact: Saleh Binsaleh, MD    +966502100034    surgon@hotmail.com   
Sponsors and Collaborators
Elaj medical centers
King Saud University
Investigators
Layout table for investigator information
Study Director: Saleh Binsaleh, MD King Saud University

Layout table for additonal information
Responsible Party: Mohamad Habous, Dr Mohamad Habous, Elaj medical centers
ClinicalTrials.gov Identifier: NCT02665520     History of Changes
Other Study ID Numbers: Elaj stem cells 1
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Mohamad Habous, Elaj medical centers:
stem cells injections
erectile dysfunction
Additional relevant MeSH terms:
Layout table for MeSH terms
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders