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Trial record 51 of 498 for:    penis

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

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE January 27, 2016
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
Official Title  ICMJE Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE Procedure: liposuction for retrieval of own stem cells from fat cells
Study Arms  ICMJE
  • Active Comparator: stem cells injection in penis
    Treatment Injection of adipose derived cells into penis experimental;randomised
    Intervention: Procedure: liposuction for retrieval of own stem cells from fat cells
  • No Intervention: controled arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 26, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02665520
Other Study ID Numbers  ICMJE Elaj stem cells 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohamad Habous, Elaj medical centers
Study Sponsor  ICMJE Elaj medical centers
Collaborators  ICMJE King Saud University
Investigators  ICMJE
Study Director: Saleh Binsaleh, MD King Saud University
PRS Account Elaj medical centers
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP