The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.
The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
UC-MSC secretome was obtained from UC-MSC cultures with 80% confluence in serum-free medium after 24 hours of incubation The VEGF level in the secretome given was 1400 pg/ml. The intervention was the administration of 0.5 mL/site of secretome injection injected intra-cavernous to all subjects using a 22-gauge needle according to a sterile protocol. The same volume was given at bilateral sites of the penile shaft. The intra-cavernous injection sites were in the right and left dorsolateral regions of the penis. After the intervention, tolerability was assessed by observing and questioning the subjects regarding pain during injection.
Visual analog scale
A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Time frame: one hour and one year
Hematomes
Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.
Time frame: one hour
Bleeding
Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Time frame: one hour
Erection hardness score
Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)
Time frame: one year
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