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

October 15, 2015 updated by: Martha Haahr M.D

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense Universitet Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adipose derived stem cells
Other: adipose derived stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 1 month after surgery
Adverse Events
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in erectile function, measured i IIEF-5 score
Time Frame: 1,3,6,9 and 12 months
Assessed by interview and questionnaires
1,3,6,9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martha Haahr M.D

Collaborators

Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-Afd-L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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