Short summary

In Peyronie's disease (PD) results in fibrosis, pain, penile curvature and often erectile dysfunction. The prevalence varies from 5-9%.

We want to investigate if a single injection of autologous stromal vascular fraction into a plaque is a safe and suitable treatment in 23 Danish adult men with PD.

Rationale

Stem cells promote growth and repair thereby regenerating tissue locally in a paracrine way. They are thought to be released from a perivascular location where they are activated to regenerate the micro-environment and regulate the local immune response.

In a rat adipose derived Stem Cells showed prevention of fibrosis and elastosis in the tunica albuginea and corpus cavernosum of the rat in the acute and chronic phase of the disease. Two human studies with stem cells has shown promising results. Only 5 + 11 patientes were treated.

Description of the cohort

23 Danish men > 18 years with PD in the chronic phase

Data and biological material

Primary endpoint regarding the stem cell treatment:

A reduction of the bend of 17 degrees or more compared with baseline [measured at baseline, 1, 3, 6, 12 months]

Penile Plaque size (mm3) [measured at baseline, 1, and 12 months]

International Index of Erectile Function (IIEF5) (21) [measured at baseline, 1, 3, 6, 12 months].

Peyronie´s disease questionnaire (PDQ) (6) [measured at baseline, 1, 3, 6, 12 months]

Stretched Penile Length from symphysis to meatus of the glans (cm) [measured at baseline, 1, and 12 months]

Collaborating researchers and departments

Department of urology, OUH

• Professor Lars Lund

Department of plastic surgery, OUH

• Professor Jens Ahm Sørensen

Department of Clinical Biochemistry and Pharmacology, OUH

• Charlotte Harken Jensen

Department of Urology, SVS