Back to resultsManagement of Peyronie's Disease With Adipose Tissue Stem Cell
Primary Purpose
Erectile Dysfunction, Peyronie' Disease
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Adipose tissue stem cell injection
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Peyronie's disease, stem cell
Eligibility Criteria
Inclusion Criteria:
- erectile dysfunction associated with Peyroni's diseas
Exclusion Criteria:
- nil
Sites / Locations
- Man clinicRecruiting
- Man clinic for andrology and male infertilityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adipose tissue stem cell injection
Arm Description
The stem cell will be harvested by liposuction and injection will be at corpora cavernosa and dorsal penile artery
Outcomes
Primary Outcome Measures
sexual function questionnaire
Clinical history of patients before and after treatment Penile duplex study
Secondary Outcome Measures
Penile plaque assessment
Clinical examination Patient history Penile duplex
Full Information
NCT ID
NCT02414308
First Posted
January 6, 2014
Last Updated
April 9, 2015
Sponsor
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
1. Study Identification
Unique Protocol Identification Number
NCT02414308
Brief Title
Management of Peyronie's Disease With Adipose Tissue Stem Cell
Official Title
The Role of Adipose Tissue Stem Cell Injection Through Corpora Cavernosa and Intra Dorsal Penile Artery in Management of Erectile Dysfunction Associated With Peyronie's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results We can start conservative treatment and then surgical treatment if fail but the outcome still not convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis We start to use stem cell in patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under Doppler device guidance
Detailed Description
Peyronie's disease associated with erectile dysfunction nan be treated by different methods We start to treat such patients with adipose tissue stem cell Harvesting stem cell from adipose tissue and injected into corpora cavernosa and penile artery and we assess quality of erection through patient history and penile duplex and also assess plaque size and other symptoms related to Peyronie's disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Peyronie' Disease
Keywords
Erectile dysfunction, Peyronie's disease, stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adipose tissue stem cell injection
Arm Type
Experimental
Arm Description
The stem cell will be harvested by liposuction and injection will be at corpora cavernosa and dorsal penile artery
Intervention Type
Drug
Intervention Name(s)
Adipose tissue stem cell injection
Intervention Description
Stem cell will be harvested through adipose tissue by liposuction and isolation occurred Injection will distribute through corpora cavernosa and dorsal penile artery
Primary Outcome Measure Information:
Title
sexual function questionnaire
Description
Clinical history of patients before and after treatment Penile duplex study
Time Frame
2-3 months
Secondary Outcome Measure Information:
Title
Penile plaque assessment
Description
Clinical examination Patient history Penile duplex
Time Frame
2-3 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
erectile dysfunction associated with Peyroni's diseas
Exclusion Criteria:
nil
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled A Gadalla, MD, ABS
Phone
20222725025
Email
Khaledgadalla@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD, ABS
Organizational Affiliation
Man clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Man clinic
City
Cairo
ZIP/Postal Code
11366
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD, ABS
Phone
20222725025
Email
Khaledgadalla@gmail.com
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD, ABS
Facility Name
Man clinic for andrology and male infertility
City
Cairo
ZIP/Postal Code
33611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD, ABS
Phone
20222725025
Email
Khaledgadalla@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Management of Peyronie's Disease With Adipose Tissue Stem Cell
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