drugset / Trial / NCT04771442

Stem Cell Treatment of Peyronie´s Disease.

NCT04771442

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-09-09
Primary completion
2023-12-15
Completion
2024-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexlemestrocel-L Cell therapy Subcutaneous

Indications