Back to resultsPenile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Unknown status
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
liposuction for retrieval of own stem cells from fat cells
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring stem cells injections, erectile dysfunction
Eligibility 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
Sites / Locations
- Elaj medical groupRecruiting
- kING SAUD UNIVERSITYRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
stem cells injection in penis
controled arm
Arm Description
Treatment Injection of adipose derived cells into penis experimental;randomised
Outcomes
Primary Outcome Measures
Adverse Events that occur during or after the procedure to measure safety and tolerability
to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients
Secondary Outcome Measures
Full Information
NCT ID
NCT02665520
First Posted
March 9, 2015
Last Updated
January 26, 2016
Sponsor
Elaj medical centers
Collaborators
King Saud University
1. Study Identification
Unique Protocol Identification Number
NCT02665520
Brief Title
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
Official Title
Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Elaj medical centers
Collaborators
King Saud University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
stem cells injections, erectile dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stem cells injection in penis
Arm Type
Active Comparator
Arm Description
Treatment Injection of adipose derived cells into penis experimental;randomised
Arm Title
controled arm
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
liposuction for retrieval of own stem cells from fat cells
Primary Outcome Measure Information:
Title
Adverse Events that occur during or after the procedure to measure safety and tolerability
Description
to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MOHAMAD HABOUS, M.D;FEBU
Phone
+966599950131
Email
drmhabos@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saleh Binsaleh, MD
Phone
+966502100034
Email
surgon@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saleh Binsaleh, MD
Organizational Affiliation
King Saud University
Official's Role
Study Director
Facility Information:
Facility Name
Elaj medical group
City
Jedda
State/Province
Outside U.S./Canada
ZIP/Postal Code
21463
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Habous
Phone
+966599950131
Email
drmhabos@hotmail.com
First Name & Middle Initial & Last Name & Degree
Saleh Binsaleh, MD
Facility Name
kING SAUD UNIVERSITY
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saleh Binsaleh, MD
Phone
+966502100034
Email
surgon@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction
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