NCT02414308

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

January 6, 2014

Last Update Submit

April 9, 2015

Conditions

Keywords

Erectile dysfunction, Peyronie's disease, stem cell

Outcome Measures

Primary Outcomes (1)

  • sexual function questionnaire

    Clinical history of patients before and after treatment Penile duplex study

    2-3 months

Secondary Outcomes (1)

  • Penile plaque assessment

    2-3 months

Study Arms (1)

Adipose tissue stem cell injection

EXPERIMENTAL

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

Interventions

Stem cell will be harvested through adipose tissue by liposuction and isolation occurred Injection will distribute through corpora cavernosa and dorsal penile artery

Adipose tissue stem cell injection

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • erectile dysfunction associated with Peyroni's diseas

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Man clinic for andrology and male infertility

Cairo, Cairo Governorate, 33611, Egypt

RECRUITING

Man clinic

Cairo, 11366, Egypt

RECRUITING

MeSH Terms

Conditions

Erectile DysfunctionBalanitis Xerotica ObliteransPenile Induration

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersBalanitisPenile DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Khaled A Gadalla, MD, ABS

    Man clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled A Gadalla, MD, ABS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 6, 2014

First Posted

April 10, 2015

Study Start

June 1, 2013

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations