Delayed Graft Function
Conditions
Keywords
Erectile Function, Mesenchymal Stromal Cells, Stem Cell
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Odense University Hospital
Martha Haahr M.D
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men who have had prostate removed due to prostate cancer regardless bilateral nerve-sparing, unilateral nerve-sparing or non-nerve-sparing surgical technique. * Erectile dysfunction * Sexually active/ have sexual interest * We make no distinction for the patients are operated with
Exclusion criteria
* Absence of sexual interest. * Patients with impaired health condition where anesthesia would be a risk of complications. * BMI below 20. * Small amount of abdominal fat assessed by. Ct abdomen. * Patients on anticoagulant treatment. * Men with suspicion of residual tumor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 1 month after surgery | Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in erectile function, measured i IIEF-5 score | 1,3,6,9 and 12 months | Assessed by interview and questionnaires |
Countries
Denmark
Outcome results
None listed