Injectable Collagen Scaffold™ Combined With HUC-MSCs 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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 ]
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): NCT02745808
|Contact: Zhifeng Xiao, Ph.Demail@example.com|
|Contact: Sufang Han, Ph.Dfirstname.lastname@example.org|
|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 email@example.com|
|Contact: LeiLei Zhu, M.D. 86-25-83106666 ext 70502 firstname.lastname@example.org|
|Principal Investigator:||Jianwu Dai, Ph.D||Chinese Academy of Sciences|