Short summary

At a pilot study in 2014, we have demonstrated that treatment of erectile dysfunction in men with prostatectomy fat derived stem cells were safe and tolerable. Now, we wish to investigate the effect closer with a randomized, placebo-controlled, double-blind clinical study.

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Rationale

Prostate cancer is the most common cancer among Danish men and the incidence is increasing. In 2014, 4581 new cases were diagnosed of which 1084 was subsequently operated. After prostatectomy, 80% experience erectile dysfunction, the current option for penile rehabilitation is using PDE-5i (of phosphodiesterase type-5 inhibitors) that, in these patients, only has effect in approximately 27%. The sexual life is a central part of people's identity, self-esteem and quality of life. There is no medical treatment for erectile dysfunction, but far from all patients will be adequately helped and new permanent treatments are called for, both by patients and therapists.

Stem cell therapy has potential as an alternative intervention for many patients who do not have sufficient therapeutic effect of phosphodiesterase type-5 inhibitors.

After prostatectomy, the temporary nerve dysfunction (stretch on the nerve, inflammation and bleeding) leads to structural changes in penile tissue. This is believed to be linked to the oxygen tension, which is 25-43 mmHg in a non-erect penis while it rises to about 100 mmHg in the erect state. In the neuropraxi periode, the penile tissue is in a constant state of low oxygen supply, which leads to muscle apoptosis and fibrosis. This interferes with the veno-occlusive mechanism, which is essential in normal erectile function, thus resulting in the temporary neuronal dysfunction to structural damage which may be a contributory factor to prolonged ED after nerve-sparing prostatectomy. It has been repeatedly shown in animal models that there is a reduction in the smooth muscle tissue.

The fat stem cells accelerates tissue regeneration, presumably by releasing hormones, cytokines and growth factors but also by developing into new terminally differentiated cells, such as skin, endothelial and muscle cells.

In 2014-2015, we have conducted our own Phase 1 study (Eudra CT number 2013-004220-11) where freshly isolated stem cells were injected into the swell bodies of men who had erectile dysfunction after prostatectomy. We included 17 men, 3-18 months after prostatectomy. All men could be included if they had sexual interest. The men were seen for clinical follow-up 1, 3, 6 and 12 months after treatment with stem cells. Here we found that 73% of men who had only erectile dysfunction regained erectile function 3-6 months after treatment. The men who suffered from erectile dysfunction and also had urinary incontinence had some effect, but not sufficient improvement of erectile ability in order to complete sexual intercourse. Along the study, the men who were suffering a lot from urinary incontinence lost the sexual interest as the incontinence problem loomed larger. There were not registered serious side effects in subjects and modest generation after liposuction.

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Description of the cohort

Prostatectomy men with erectile dysfunction without signs of recurrence.

Data and biological material

We collect basic data from patient records.

Biological material in the form of fat from liposuction of the abdomen.

The investigator and the person responsible for the trial are a doctor and sexologist. Mostly, patients are known from the sexology ambulatory, the Department of Urology, Odense University Hospital, which they were referred to as a cause of sexual dysfunctions. The investigator and the person responsible for the trial will have a doctor-patient contact with the subjects that come due to erectile dysfunction.

Information is passed on from the patient record to the person responsible for the trial regarding diagnosis, medical history, treatment, events and reactions, with the aim to collect and process data in the study.

Collaborating researchers and departments

Department of Urology, Odense University Hospital

• Primary investigator Martha Haahr

Department of Clinical Biochemistry and Pharmacology, Odense University Hospital

• Sponsor Søren Paludan Sheikh
• Charlotte Harken Jensen

GCP-unit, Odense University Hospital

Department of Plastic Surgery, Odense University Hospital