<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/NCT03803917</url>
  </required_header>
  <id_info>
    <org_study_id>AT_ Fistula_observational</org_study_id>
    <nct_id>NCT03803917</nct_id>
  </id_info>
  <brief_title>Adipose Tissue in Crohn´s Disease Fistulas</brief_title>
  <official_title>Treatment of Perianal Fistulas in Crohn's Disease With Injection of Freshly Harvested Autologous Adipose Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lilli Lundby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Present study investigated the efficacy of injection of freshly collected autologous adipose&#xD;
      tissue into perianal fistulas in patients with Crohn's disease. Adipose tissue collected by&#xD;
      liposuction was injected into the perianal fistulas. Primary objective was complete clinical&#xD;
      healing six months after treatment. Secondary objectives were reduced or ceased fistula&#xD;
      secretion and complications to the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators prospectively registered symptoms, complications and results of treatment in 21&#xD;
      patients with Crohn´s Disease who underwent treatment with freshly harvested autologous&#xD;
      adipose tissue for perianal fistulas between March 2015 and June 2018. Inclusion criteria&#xD;
      consisted of the following: the presence of complex CD fistulas refractory to standard&#xD;
      surgical intervention, including long-term seton and regular curettage, and/or medical&#xD;
      treatment. Pelvic magnetic resonance imaging (MRI) was performed to describe the location and&#xD;
      extent of the fistula. Clinical examinations of the patients were performed at intervals of&#xD;
      six weeks, three months and six months following adipose tissue injection. Primary endpoint&#xD;
      was complete fistula healing at clinical examination six months after the last injection. A&#xD;
      fistula was considered completely clinically healed: (i) if the patient had no symptoms of&#xD;
      discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii)&#xD;
      if no internal opening could be palpated with rectal digital examination. Secondary endpoints&#xD;
      included either reduced or ceased fistula secretion. If clinical healing of the fistula was&#xD;
      not obtained six weeks after the first treatment, patients were offered a second adipose&#xD;
      injection within two weeks. A third injection was offered to patients who did not have&#xD;
      complete healing within six weeks of the first two injections.Pelvic MRI was repeated in all&#xD;
      patients with transsphincteric and intersphincteric fistulas who, upon clinical examination,&#xD;
      demonstrated complete healing at 6 months after the last injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical healing</measure>
    <time_frame>6 months after last injection</time_frame>
    <description>A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ceased or reduced fistula secretion</measure>
    <time_frame>6 months after last injection</time_frame>
    <description>Reported by the individual patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications to the treatment</measure>
    <time_frame>6 months after last injection</time_frame>
    <description>Reported by the individual patient and findings by clinical examination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Crohn Disease</condition>
  <condition>Perianal Fistula</condition>
  <condition>Tissue Transplantation</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Injection with freshly collected autologous adipose tissue</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Injection with freshly collected autologous adipose tissue</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Crohn´s Disease&#xD;
&#xD;
          -  presence of complex Crohn´s Disease fistulas&#xD;
&#xD;
          -  fistulas refractory to standard surgical intervention, including long-term seton and&#xD;
             regular curettage, and/or medical treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Fistulas developed following proctectomy were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Lilli Lundby</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03803917
org study id: AT_ Fistula_observational
nct id: NCT03803917
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Present study investigated the efficacy of injection of freshly collected autologous adipose
      tissue into perianal fistulas in patients with Crohn's disease. Adipose tissue collected by
      liposuction was injected into the perianal fistulas. Primary objective was complete clinical
      healing six months after treatment. Secondary objectives were reduced or ceased fistula
      secretion and complications to the treatment.
Investigators prospectively registered symptoms, complications and results of treatment in 21
      patients with Crohn´s Disease who underwent treatment with freshly harvested autologous
      adipose tissue for perianal fistulas between March 2015 and June 2018. Inclusion criteria
      consisted of the following: the presence of complex CD fistulas refractory to standard
      surgical intervention, including long-term seton and regular curettage, and/or medical
      treatment. Pelvic magnetic resonance imaging (MRI) was performed to describe the location and
      extent of the fistula. Clinical examinations of the patients were performed at intervals of
      six weeks, three months and six months following adipose tissue injection. Primary endpoint
      was complete fistula healing at clinical examination six months after the last injection. A
      fistula was considered completely clinically healed: (i) if the patient had no symptoms of
      discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii)
      if no internal opening could be palpated with rectal digital examination. Secondary endpoints
      included either reduced or ceased fistula secretion. If clinical healing of the fistula was
      not obtained six weeks after the first treatment, patients were offered a second adipose
      injection within two weeks. A third injection was offered to patients who did not have
      complete healing within six weeks of the first two injections.Pelvic MRI was repeated in all
      patients with transsphincteric and intersphincteric fistulas who, upon clinical examination,
      demonstrated complete healing at 6 months after the last injection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical healing
time frame: 6 months after last injection
description: A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination
measure: Ceased or reduced fistula secretion
time frame: 6 months after last injection
description: Reported by the individual patient
measure: Complications to the treatment
time frame: 6 months after last injection
description: Reported by the individual patient and findings by clinical examination
arm group label: Treatment
arm group type: Other
description: Injection with freshly collected autologous adipose tissue
intervention type: Procedure
intervention name: Injection with freshly collected autologous adipose tissue
arm group label: Treatment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Lilli Lundby
investigator title: Principal investigator
mesh term: Crohn Disease
mesh term: Fistula
sharing ipd: No