Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
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|ClinicalTrials.gov Identifier: NCT02745808|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus||Biological: HUC-MSCs Biological: Injectable Collagen Scaffold + HUC-MSCs||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) for the Improvement of Erectile Function in Men With Diabetes|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Intracavernous injection of 15 million HUC-MSCs.
The subjects will receive intracavernous injection of HUCMSC.
Experimental: Injectable Collagen Scaffold + HUC-MSCs
Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs.
Biological: Injectable Collagen Scaffold + HUC-MSCs
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
- Safety and Tolerability assessed by Adverse Events [ Time Frame: 1 month after intervention ]
- Improvement in IIEF-5 (International Index of Erectile Function) [ 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
- Improvement in penile colour Doppler ultrasonography [ Time Frame: 1,3,6,9 and 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745808
|Contact: Zhifeng Xiao, Ph.Dfirstname.lastname@example.org|
|Contact: Sufang Han, Ph.Demail@example.com|
|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School||Recruiting|
|Nanjing, Jiangsu, China, 210008|
|Contact: Yutian Dai, M.D. 86-25-83106666 ext 70502 firstname.lastname@example.org|
|Contact: LeiLei Zhu, M.D. 86-25-83106666 ext 70502 email@example.com|
|Principal Investigator:||Jianwu Dai, Ph.D||Chinese Academy of Sciences|