Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) for the Improvement of Erectile Function in Men With Diabetes

Conditions
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Erectile Dysfunction, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Biological: HUC-MSCs
* Biological: Injectable Collagen Scaffold + HUC-MSCs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HUC-MSCs<br>Intracavernous injection of 15 million HUC-MSCs. | Biological: HUC-MSCs<br>* The subjects will receive intracavernous injection of HUCMSC.<br>|
| Experimental: Injectable Collagen Scaffold + HUC-MSCs<br>Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs. | Biological: Injectable Collagen Scaffold + HUC-MSCs<br>* The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability assessed by Adverse Events |  | 1 month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in IIEF-5 (International Index of Erectile Function) | The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function | 1,3,6,9 and 12 months | 
| Improvement in penile colour Doppler ultrasonography |  | 1,3,6,9 and 12 months |