Purpose of the project is to investigate if a single injection of autologous stromal vascular fraction into and around plaque is a safe and suitable treatment. Twentythree men \> 18 years with Peyronie´s Disease in the chronic phase will be recruited. The operative same-day procedure will be performed in general anaesthesia by a plastic surgeon. Before the patient wake, local anaesthesia is put around the penis. Processed stem cells are injected into the plaque/fibrosis subcutaneously. There will be a follow up at 1, 3, 6, 12 months. It is a pilot study with no randomisation. The group will be compared to a historical control group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Single dose
Sydvejstjysk Sygehus
Esbjerg, Denmark
Change in the bend of the erect penis
Changes in degrees measured with a goniometer compared to baseline
Time frame: [measured at baseline, 1, 3, 6, 12 months]
Change in Peyronie´s disease questionnaire bother symptoms
Will there be less bother symptoms compared to baseline? Score 0-44. The higher the score the more symptoms.
Time frame: [measured at baseline, 1, 3, 6, 12 months]
Change in International Index of Erectile Function score,
Score can be 5-25, the higher the score the less symptoms. Answers are compared to baseline.
Time frame: [measured at baseline, 1, 3, 6, 12 months].
Change in stretched Penile Length from symphysis to meatus of the glans (cm)
Ruler
Time frame: [measured at baseline, 1, and 12 months]
Change in penile Plaque size (mm3)
Ultrasonic scanner
Time frame: [measured at baseline, 1, and 12 months]
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