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Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 3, 2014
First Posted Date  ICMJE September 16, 2014
Last Update Posted Date October 16, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
Safety and Tolerability [ Time Frame: 1 month after surgery ]
Adverse Events
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
Improvement in erectile function, measured i IIEF-5 score [ Time Frame: 1,3,6,9 and 12 months ]
Assessed by interview and questionnaires
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
Improvement in erectile function, measured i IIEF-5 score [ Time Frame: 1,3,6,9 and 12 months ]
Assessed by interview and questionnaires
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
Safety and Tolerability [ Time Frame: 1 month after surgery ]
Adverse Events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
Official Title  ICMJE Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Delayed Graft Function
Intervention  ICMJE Other: adipose derived stem cells
Study Arms  ICMJE Experimental: adipose derived stem cells
Intervention: Other: adipose derived stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 12, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02240823
Other Study ID Numbers  ICMJE 2013-Afd-L
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martha Haahr M.D, Odense University Hospital
Study Sponsor  ICMJE Martha Haahr M.D
Collaborators  ICMJE Odense University Hospital
Investigators  ICMJE Not Provided
PRS Account Odense University Hospital
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP