Safety of Wharton Jelly in Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT02945449|
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Associated With Type 2 Diabetes Mellitus||Biological: Wharton Jelly Mesenchymal stem cells||Phase 1|
This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which nine 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib: Evaluation of the Safety and as a Secondary End Point the Efficacy for Two Doses of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction|
|Actual Study Start Date :||January 4, 2017|
|Actual Primary Completion Date :||October 15, 2018|
|Actual Study Completion Date :||November 2018|
Experimental: Dose I
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.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 6 months ]Patients will be assessed for any relevant adverse event resulting from the intracavernous injection of the Wharton jelly mesenchymal stem cells.
- Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire [ Time Frame: 12 months ]Patients will be evaluated for the efficacy of the intracavernous injection of Wharton Jelly derived Mesenchymal Stem Cells by Sexual Health Inventory for Men/International Index of Erectile Function/Erection Hardness Score (SHIM/IIEF/EHS) questionnaire.
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): NCT02945449
|Cell Therapy Center|
|Amman, Jordan, 11942|
|Study Director:||Abdallah Awidi, MD||Cell Therapy Center|