drugset / Trial / NCT04771442
Stem Cell Treatment of Peyronie´s Disease.
Phase 1
Completed
22 enrolled
Esbjerg Hospital - University Hospital of Southern Denmark
Odense University Hospital · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rexlemestrocel-L | Cell therapy | — | Subcutaneous |