NCT04771442

Stem Cell Treatment of Peyronie´s Disease.

Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Penile Induration
• Penile Diseases

Interventions

Type	Name	Description
DRUG	Stromal vascular fraction	Single dose

Timeline

• Start date: 2022-09-09
• Primary completion: 2023-12-15
• Completion: 2024-05-30
• First posted: 2021-02-25
• Last updated: 2024-07-31

Locations

1 site across 1 country: Denmark