- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02665520
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
January 26, 2016 updated by: Mohamad Habous, Elaj medical centers
Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MOHAMAD HABOUS, M.D;FEBU
- Phone Number: +966599950131
- Email: drmhabos@hotmail.com
Study Contact Backup
- Name: Saleh Binsaleh, MD
- Phone Number: +966502100034
- Email: surgon@hotmail.com
Study Locations
-
-
-
Riyadh, Saudi Arabia
- Recruiting
- King Saud University
-
Contact:
- Saleh Binsaleh, MD
- Phone Number: +966502100034
- Email: surgon@hotmail.com
-
-
Outside U.S./Canada
-
Jedda, Outside U.S./Canada, Saudi Arabia, 21463
- Recruiting
- Elaj medical group
-
Contact:
- Mohamad Habous
- Phone Number: +966599950131
- Email: drmhabos@hotmail.com
-
Principal Investigator:
- Saleh Binsaleh, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: stem cells injection in penis
Treatment Injection of adipose derived cells into penis experimental;randomised
|
|
No Intervention: controled arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Saleh Binsaleh, MD, King Saud University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
January 26, 2016
First Posted (Estimate)
January 27, 2016
Study Record Updates
Last Update Posted (Estimate)
January 27, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Elaj stem cells 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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