<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02240823</url>
  </required_header>
  <id_info>
    <org_study_id>2013-Afd-L</org_study_id>
    <nct_id>NCT02240823</nct_id>
  </id_info>
  <brief_title>Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy</brief_title>
  <official_title>Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Martha Haahr M.D</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer is the most common cancer among Danish men, and the incidence is increasing.&#xD;
      Studies have shown a high number needed to treat for each saved prostate cancer related&#xD;
      death. Since the treatments incur many complications, there is a need to address these. After&#xD;
      prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's&#xD;
      identity, self-esteem and quality of life. Stem cells have generated a large amount of&#xD;
      promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating&#xD;
      nerves as well as endothelial and smooth muscle cells in the corpus cavernous.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is the most common cancer among Danish men, and the incidence is increasing.&#xD;
      Studies have shown a high number needed to treat for each saved prostate cancer related&#xD;
      death.&#xD;
&#xD;
      After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of&#xD;
      people's identity, self-esteem and quality of life. Stem cells have generated a large amount&#xD;
      of promising data suggesting that stem cells can alleviate erectile dysfunction, by&#xD;
      regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.&#xD;
&#xD;
      Animal studies have used stem cell therapy to improve erectile dysfunction in rats after&#xD;
      cavernous nerve damage, with invariable high success rate.&#xD;
&#xD;
      In this pilot study will include 30 patient's with erectile dysfunction 3-9 mdr after&#xD;
      prostatectomy. The men have no spontaneous erectile function and no response to drug&#xD;
      treatment.&#xD;
&#xD;
      Liposuction is carried out in general anesthesia. Isolation of stem cells will be done&#xD;
      simultaneously and the stem cells injected into the corpus cavernous directly after the&#xD;
      isolation is carried out.&#xD;
&#xD;
      This is a clinical study evaluating an innovative cell therapy procedure.The objective of&#xD;
      this study was to evaluate the effects of injection of stem cell of adipose origin.&#xD;
&#xD;
      The project will run over a period of twelve months. Patients will be followed for a period&#xD;
      of six months. Treatment efficacy will be assessed from validated questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in erectile function, measured i IIEF-5 score</measure>
    <time_frame>1,3,6,9 and 12 months</time_frame>
    <description>Assessed by interview and questionnaires</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Delayed Graft Function</condition>
  <arm_group>
    <arm_group_label>adipose derived stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>adipose derived stem cells</intervention_name>
    <arm_group_label>adipose derived stem cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men who have had prostate removed due to prostate cancer regardless bilateral&#xD;
             nerve-sparing, unilateral nerve-sparing or non-nerve-sparing surgical technique.&#xD;
&#xD;
          -  Erectile dysfunction&#xD;
&#xD;
          -  Sexually active/ have sexual interest&#xD;
&#xD;
          -  We make no distinction for the patients are operated with&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of sexual interest.&#xD;
&#xD;
          -  Patients with impaired health condition where anesthesia would be a risk of&#xD;
             complications.&#xD;
&#xD;
          -  BMI below 20.&#xD;
&#xD;
          -  Small amount of abdominal fat assessed by. Ct abdomen.&#xD;
&#xD;
          -  Patients on anticoagulant treatment.&#xD;
&#xD;
          -  Men with suspicion of residual tumor.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Odense Universitet Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>June 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 15, 2015</last_update_submitted>
  <last_update_submitted_qc>October 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Martha Haahr M.D</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>Erectile Function</keyword>
  <keyword>Mesenchymal Stromal Cells</keyword>
  <keyword>Stem Cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
    <mesh_term>Delayed Graft Function</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 12, 2016</submitted>
    <returned>October 31, 2016</returned>
    <submitted>November 1, 2016</submitted>
    <returned>December 29, 2016</returned>
    <submitted>May 2, 2017</submitted>
    <returned>August 11, 2017</returned>
    <submitted>August 14, 2017</submitted>
    <returned>February 16, 2018</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02240823
org study id: 2013-Afd-L
nct id: NCT02240823
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Tolerability
time frame: 1 month after surgery
description: Adverse Events
measure: Improvement in erectile function, measured i IIEF-5 score
time frame: 1,3,6,9 and 12 months
description: Assessed by interview and questionnaires
arm group label: adipose derived stem cells
arm group type: Experimental
intervention type: Other
intervention name: adipose derived stem cells
arm group label: adipose derived stem cells
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Odense University Hospital
investigator full name: Martha Haahr M.D
investigator title: Medical doctor
mesh term: Erectile Dysfunction
mesh term: Delayed Graft Function
submitted: September 12, 2016
returned: October 31, 2016
submitted: November 1, 2016
returned: December 29, 2016
submitted: May 2, 2017
returned: August 11, 2017
submitted: August 14, 2017
returned: February 16, 2018