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 : Unknown
Verified April 2016 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was: Recruiting
First Posted : April 20, 2016
Last Update Posted : January 25, 2019
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: HUC-MSCs
Intracavernous injection of 15 million HUC-MSCs.
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Biological: 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.
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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 ]

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Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i
- Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study
- Males, age 20-65 years
- IIEF-5 score is under 16
- Penile arterial insufficiency or venous leakage (doppler): peak systolic velocity(PSV) <25 cm/sec, or peak systolic velocity(PSV)>25 cm/sec, end-diastolic velocity(EDV)> 5cm/sec, resistance index(RI)<0.75
- HbA1c is between 6.5%-10%
- Physical examination with no abnormalities
- Willing to consent to participate in the study follow-up
- Willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.
Exclusion Criteria:
- Severe cardiovascular disease (angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy
- Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test
- Testosterone level is less than 200ng/dL
- Serum AST/ALT >3*upper limit of normal or creatinine >1.5*upper limit of normal
- HbA1c exhibit greater than 10%
- In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery
- Patients partner is trying to conceive during the trial period
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study
- Unwilling and/or not able to give written informed consent

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.D | 86-10-82614420 | zfxiao@genetics.ac.cn | |
Contact: Sufang Han, Ph.D | 86-10-82614420 | sufanghan22@genetics.ac.cn |
China, Jiangsu | |
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 13913957628@163.com | |
Contact: LeiLei Zhu, M.D. 86-25-83106666 ext 70502 zhuleilei68n@163.com |
Principal Investigator: | Jianwu Dai, Ph.D | Chinese Academy of Sciences |
Responsible Party: | Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences |
ClinicalTrials.gov Identifier: | NCT02745808 |
Other Study ID Numbers: |
CAS-XDA-DEF/IGDB |
First Posted: | April 20, 2016 Key Record Dates |
Last Update Posted: | January 25, 2019 |
Last Verified: | April 2016 |
Erectile Dysfunction Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |