Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
Study Details
Study Description
Brief Summary
The intent of this clinical study is to answer the questions: 1) is the proposed treatment feasible; 2) is treatment effective in improving the disease pathology of patients with diagnosed diabetic erectile dysfunction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HUC-MSCs Intracavernous injection of 15 million HUC-MSCs. |
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. |
Biological: Injectable Collagen Scaffold + HUC-MSCs
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability assessed by Adverse Events [1 month after intervention]
Secondary Outcome Measures
- Improvement in IIEF-5 (International Index of Erectile Function) [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 [1,3,6,9 and 12 months]
Eligibility Criteria
Criteria
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
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Willing to consent to participate in the study follow-up
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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
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Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test
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Testosterone level is less than 200ng/dL
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Serum AST/ALT >3upper limit of normal or creatinine >1.5upper limit of normal
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HbA1c exhibit greater than 10%
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In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery
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Patients partner is trying to conceive during the trial period
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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
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Unwilling and/or not able to give written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China | 210008 |
Sponsors and Collaborators
- Chinese Academy of Sciences
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
- Principal Investigator: Jianwu Dai, Ph.D, Chinese Academy of Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAS-XDA-DEF/IGDB