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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China
Tolerance
Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
Time frame: 1-4 weeks after each injection
Short-term effects on erectile function
Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
Time frame: 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
Time frame: 12 months after final injection
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