Collagen Scaffolds Loaded With HUCMSCs 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.

Detailed Description
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Intracavernous transplantation of stem cells has been shown to improve erectile function in some preclinical studies. However, inadequate cell homing to damaged sites limited its functions. The investigators explore the effect of HUCMSC on improving erectile function of diabetic men, and whether collagen scaffolds contribute to long-term cell retention in the corpus cavernous and improves erectile function of diabetic men.

Official Title
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Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells 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: HUCMSC injection
* Biological: collagen scaffolds/HUCMSC injection


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): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, RI<0, 75; HbA1c is between 6.5% 10%; physical examination with no abnormalities; who is 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: HUCMSC injection<br>once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells | Biological: HUCMSC injection<br>* The subjects will receive intracavernous injection of HUCMSC.'<br>|
| Experimental: collagen scaffolds/HUCMSC injection<br>once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells | Biological: collagen scaffolds/HUCMSC injection<br>* The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in IIEF scores | The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function. | 1,3,6,9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection |  | 1,3,6,9 and 12 months | 
| Safety and Tolerability assessed by Adverse Events |  | 1 month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, stem cell, collagen scaffold