Sydvejstjysk Sygehus
Esbjerg, 6700, Denmark
NCT Number: NCT04771442
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.
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Notify Me18 year–80 year
Male
Interventional
Phase 1
Esbjerg, 6700, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients may not be:
Single dose
Other names: SVF
Time frame: [measured at baseline, 1, 3, 6, 12 months]
Changes in degrees measured with a goniometer compared to baseline
Time frame: [measured at baseline, 1, 3, 6, 12 months]
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].
Score can be 5-25, the higher the score the less symptoms. Answers are compared to baseline.
Time frame: [measured at baseline, 1, and 12 months]
Ruler
Time frame: [measured at baseline, 1, and 12 months]
Ultrasonic scanner
Esbjerg Hospital - University Hospital of Southern Denmark
Other
Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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