Very Small Embryonic-like Stem Cells for Erectile Dysfunction

Study Overview
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Brief Summary
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The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to organic erectile dysfunction, such as those associated with metabolic syndrome or the treatment of prostate cancer.

Detailed Description
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By enrolling patients with organic erectile dysfunction adapted to enrolled criteria, this study will document for the first time the safety and efficacy of underlying penile cellular damage. The safety will be evaluated by tolerance degree. The efficacy will be evaluated validated scores and color duplex Doppler ultrasound.

Official Title
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Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction

Conditions
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Organic Erectile Dysfunction

Intervention / Treatment
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* Biological: Very small embryonic-like stem cell(VSEL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metabolic and systemic changes in diseases such as diabetes and atherosclerosis or more localized causes such as direct injury to the penile neurovascular supply during prostate surgery Diagnosed as an organic erectile dysfunction by at least 2 urological surgeons Exclusion Criteria: Non-organic erectile dysfunction, such as psychological factors Solid cancer patients other than early prostate cancer Blood disease patients, thrombocytopenia or dysfunction, hypofibrinogenemia or anticoagulant therapy, long-term use of aspirin Older than 70 years

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Interventional Model Description: In this group, the patients will receive intracavernous injection of autologous VSELs. The check indexes are International Index of Erectile Function 5(IIEF-5), Erection Hardness Score(EHS) and penile vascularization assessed using color duplex Doppler ultrasound (CDDU), mainly including erectile function, stretched penile length, sexual drive, intercourse satisfaction, and overall satisfaction.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSEL Max<br>Each treatment: 120,000 VSELs each time, suspending with 20 mL platelet-rich plasma(PRP), transfusion for 3 times with a interval of 1 month, intracavernous injection | Biological: Very small embryonic-like stem cell(VSEL)<br>* Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation<br>|
| Experimental: VSEL Medium<br>Each treatment: 90,000 VSELs each time, suspending with 20 mL platelet-rich plasma(PRP), transfusion for 3 times with a interval of 1 month, intracavernous injection | Biological: Very small embryonic-like stem cell(VSEL)<br>* Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation<br>|
| Experimental: VSEL Mini<br>Each treatment: 60,000 VSELs each time, suspending with 20 mL platelet-rich plasma(PRP), transfusion for 3 times with a interval of 1 month, intracavernous injection | Biological: Very small embryonic-like stem cell(VSEL)<br>* Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation<br>|
| No Intervention: Control<br>In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism | 1-4 weeks after each injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term effects on erectile function | Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function | 3-6 months after each injection | 
| Long-term effects on erectile function | Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function | 12 months after final injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, very small embryonic-like stem cell