Management of Peyronie's Disease With Adipose Tissue Stem Cell

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02414308
• Other study ID #: 003
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2014
• Last updated: April 9, 2015
• Start date: June 2013
• Est. completion date: July 2016

Study information

• Verified date: April 2015
• Source: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
• Contact: Khaled A Gadalla, MD, ABS
• Phone: 20222725025
• Email: Khaledgadalla[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• erectile dysfunction associated with Peyroni's diseas

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Penile Induration
• Peyronie' Disease

Intervention

Drug:
• Adipose tissue stem cell injection
Stem cell will be harvested through adipose tissue by liposuction and isolation occurred Injection will distribute through corpora cavernosa and dorsal penile artery

Locations

Country	Name	City	State
Egypt	Man clinic	Cairo
Egypt	Man clinic for andrology and male infertility	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sexual function questionnaire	Clinical history of patients before and after treatment Penile duplex study	2-3 months	Yes
Secondary	Penile plaque assessment	Clinical examination Patient history Penile duplex	2-3 months	Yes