Delayed Graft Function Clinical Trial
Official title:
Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death. Since the treatments incur many complications, there is a need to address these. After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's identity, self-esteem and quality of life. Stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.
Prostate cancer is the most common cancer among Danish men, and the incidence is increasing.
Studies have shown a high number needed to treat for each saved prostate cancer related
death.
After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of
people's identity, self-esteem and quality of life. Stem cells have generated a large amount
of promising data suggesting that stem cells can alleviate erectile dysfunction, by
regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.
Animal studies have used stem cell therapy to improve erectile dysfunction in rats after
cavernous nerve damage, with invariable high success rate.
In this pilot study will include 30 patient's with erectile dysfunction 3-9 mdr after
prostatectomy. The men have no spontaneous erectile function and no response to drug
treatment.
Liposuction is carried out in general anesthesia. Isolation of stem cells will be done
simultaneously and the stem cells injected into the corpus cavernous directly after the
isolation is carried out.
This is a clinical study evaluating an innovative cell therapy procedure.The objective of
this study was to evaluate the effects of injection of stem cell of adipose origin.
The project will run over a period of twelve months. Patients will be followed for a period
of six months. Treatment efficacy will be assessed from validated questionnaires.
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