Management of Peyronie's Disease With Adipose Tissue Stem Cell

April 9, 2015 updated by: Khaled Abdulmoneim Gadalla, Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11366
        • Recruiting
        • Man Clinic
        • Contact:
        • Principal Investigator:
          • Khaled A Gadalla, MD, ABS
      • Cairo, Egypt, 33611
        • Recruiting
        • Man Clinic for Andrology and male infertility
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • erectile dysfunction associated with Peyroni's diseas

Exclusion Criteria:

  • nil

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adipose tissue stem cell injection
The stem cell will be harvested by liposuction and injection will be at corpora cavernosa and dorsal penile artery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sexual function questionnaire
Time Frame: 2-3 months
Clinical history of patients before and after treatment Penile duplex study
2-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penile plaque assessment
Time Frame: 2-3 months
Clinical examination Patient history Penile duplex
2-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

Investigators

  • Principal Investigator: Khaled A Gadalla, MD, ABS, Man Clinic

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

June 1, 2013

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003 (033)

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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