Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
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|ClinicalTrials.gov Identifier: NCT02240823|
Recruitment Status : Unknown
Verified October 2015 by Martha Haahr M.D, Odense University Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2014
Last Update Posted : October 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Delayed Graft Function||Other: adipose derived stem cells||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||September 2016|
|Experimental: adipose derived stem cells||
Other: adipose derived stem cells
- Safety and Tolerability [ Time Frame: 1 month after surgery ]Adverse Events
- Improvement in erectile function, measured i IIEF-5 score [ Time Frame: 1,3,6,9 and 12 months ]Assessed by interview and questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240823
|Odense Universitet Hospital|
|Odense, Denmark, 5000|