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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
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Martha Haahr M.D, Odense University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Delayed Graft Function Other: adipose derived stem cells Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: adipose derived stem cells Other: adipose derived stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 1 month after surgery ]
    Adverse Events


Secondary Outcome Measures :
  1. Improvement in erectile function, measured i IIEF-5 score [ Time Frame: 1,3,6,9 and 12 months ]
    Assessed by interview and questionnaires


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Denmark
Odense Universitet Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Martha Haahr M.D
Odense University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Martha Haahr M.D, Medical doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02240823    
Other Study ID Numbers: 2013-Afd-L
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Martha Haahr M.D, Odense University Hospital:
Erectile Function
Mesenchymal Stromal Cells
Stem Cell
Additional relevant MeSH terms:
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Erectile Dysfunction
Delayed Graft Function
Sexual Dysfunction, Physiological
 Sexual Dysfunctions, Psychological
Mental Disorders
Pathologic Processes