Efficacy of Wharton Jelly in Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT03751735|
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Associated With Type 2 Diabetes Mellitus||Biological: Wharton Jelly Mesenchymal stem cells||Phase 1 Phase 2|
This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which 22 male patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests.
The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.
The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy for Two Doses of Intracavernous Injection of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction|
|Actual Study Start Date :||January 27, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Dose 1
Dose I of Wharton Jelly Mesenchymal stem cells (WJ-MSC) Two intracavernous injections of 20 million of WJ-MSC cells will be given to erectile dysfunction patients at baseline and 4th week of follow up
Biological: Wharton Jelly Mesenchymal stem cells
Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
- Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography. [ Time Frame: 12 months ]Patients will be evaluated for the efficacy of the intracavernous injection of Wharton Jelly derived Mesenchymal Stem Cells by Penile Doppler ultrasonography in which peak systolic velocity of the cavernosal arteries will be measured.
- Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaires [ Time Frame: 12 months ]The efficacy of the intracavernous injection of Wharton Jelly will be evaluated by scoring the SHIM/IIEF/EHS questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751735
|Contact: Sophia W AlAdwan||009625355000 ext email@example.com|
|Cell Therapy Center||Recruiting|
|Amman, Jordan, 11942|
|Contact: Sophia W AlAdwan, Msc 009625355000 ext 23960 firstname.lastname@example.org|
|Contact: Dana M Hattab, PhD 009625355000 ext 23960 email@example.com|
|Principal Investigator: Saddam Dmour, MD|
|Sub-Investigator: Abdallah Awidi, MD|
|Study Director:||Abdalla Awidi, MD||Cell Therapy Center|