Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02579148|
Recruitment Status : Withdrawn
First Posted : October 19, 2015
Last Update Posted : April 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus||Biological: HUCMSC injection Biological: collagen scaffolds/HUCMSC injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: HUCMSC injection
once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Biological: HUCMSC injection
The subjects will receive intracavernous injection of HUCMSC.'
Experimental: collagen scaffolds/HUCMSC injection
once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
Biological: collagen scaffolds/HUCMSC injection
The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'
- Improvements in IIEF scores [ Time Frame: 1,3,6,9 and 12 months ]The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.
- Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection [ Time Frame: 1,3,6,9 and 12 months ]
- Safety and Tolerability assessed by Adverse Events [ Time Frame: 1 month after intervention ]
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): NCT02579148
|Drum Tower Hospital|
|Nanjing, Jiangsu, China, 210000|
|Principal Investigator:||Jianwu Dai||Chinese Academy of Sciences|