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Policy changes have contributed to the failure to carry out smoothly
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| Name | Class |
|---|---|
| Guangzhou Four-Leaf Clover HealthTech Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSEL Max | Experimental | 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 |
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| VSEL Medium | Experimental | 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 |
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| VSEL Mini | Experimental | 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 |
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| Control | No Intervention | In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very small embryonic-like stem cell(VSEL) | Biological | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central laboratory in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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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.
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Different patients receive different numbers of cell for treatment per time
Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
| 12 months after final injection |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |