xml: <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/NCT05974280</url>
    </required_header>
    <id_info>
      <org_study_id>AP_CHAzAM_ED_001</org_study_id>
      <nct_id>NCT05974280</nct_id>
    </id_info>
    <brief_title>Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells</brief_title>
    <acronym>CHAZAM</acronym>
    <official_title>Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nantes University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nantes University Hospital</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>
        One of the newest and most innovative medicinal approaches is cell therapy. Several clinical&#xD;
        trials and experimental investigations have looked into the feasibility of treating&#xD;
        CD-related fistulas with stem cells.&#xD;
  &#xD;
        The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of&#xD;
        difficult perianal Crohn's fistulas that have not responded well to at least one conventional&#xD;
        therapy or biotherapy.&#xD;
  &#xD;
        This brand-new cell therapy medication is created using amplified allogeneic human adult&#xD;
        mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be&#xD;
        booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000&#xD;
        for a single dose of 120 million-which cannot be stored once thawed.&#xD;
  &#xD;
        Only one of the two patients receives therapy; the other serves as the backup patient. By&#xD;
        doing this, another &quot;back-up&quot; patient who might receive no care at all is avoided.&#xD;
  &#xD;
        An developing alternate approach to allogeneic ADSC injection for the treatment of&#xD;
        complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat&#xD;
        grafts have been the subject of in-depth research. They are popular because it is simple to&#xD;
        get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in&#xD;
        adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities.&#xD;
  &#xD;
        We would wish to compare the effectiveness of these two injection kinds on perianal fistulas&#xD;
        as part of our care of CD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The trial will be made available to patients who are scheduled for perianal surgery with&#xD;
        ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted&#xD;
        if the patient doesn't object.&#xD;
  &#xD;
        Two visits that correspond to typical follow-up visits for patients will be noted:&#xD;
  &#xD;
        Visit following surgery: fistula clinical evaluation, analgesic use, etc. and six months&#xD;
        after : clinical assessment, MRI&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae</measure>
      <time_frame>1 month after the surgery</time_frame>
      <description>At 1 month, the percentage of healing is defined as the clinical closure of the orifice and the lack of pus draining by pressure on the borders of the fistula scar.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Crohn Disease</condition>
    <condition>Anal Fistula</condition>
    <arm_group>
      <arm_group_label>Alofisel group</arm_group_label>
      <description>The patient receives Alofisel injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Autologous fat injection</arm_group_label>
      <description>The back-up patient receives autologous fat stem cells injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Alofisel</intervention_name>
      <description>Alofisel is made up of 'mesenchymal stem cells' from the fat tissue of a donor. Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease</description>
      <arm_group_label>Alofisel group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fat stem cell</intervention_name>
      <description>mesenchymal stem cells from adipose (fat) tissue injection</description>
      <arm_group_label>Autologous fat injection</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Population with Crohn's disease coming to the digestive surgery department of the CHU in&#xD;
          Nantes for perianal surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Complex anal fistula with the following criteria: - Inactive/slightly active luminal&#xD;
               Crohn's disease under conventional treatment or biotherapy MRI has demonstrated&#xD;
               effective drainage. Maximum of two internal orifices and three external orifices;&#xD;
               persists despite internal orifice(s) closing.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
  &#xD;
            -  Patients hypersensitive to the product, bovine serum or any of the excipients of&#xD;
               Alofisel&#xD;
  &#xD;
            -  Vulnerable persons: deprived of liberty, under guardianship, under curatorship, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
      <mesh_term>Rectal Fistula</mesh_term>
      <mesh_term>Fistula</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974280
  org study id: AP_CHAzAM_ED_001
  nct id: NCT05974280
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  One of the newest and most innovative medicinal approaches is cell therapy. Several clinical
        trials and experimental investigations have looked into the feasibility of treating
        CD-related fistulas with stem cells.
  
        The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of
        difficult perianal Crohn's fistulas that have not responded well to at least one conventional
        therapy or biotherapy.
  
        This brand-new cell therapy medication is created using amplified allogeneic human adult
        mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be
        booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000
        for a single dose of 120 million-which cannot be stored once thawed.
  
        Only one of the two patients receives therapy; the other serves as the backup patient. By
        doing this, another "back-up" patient who might receive no care at all is avoided.
  
        An developing alternate approach to allogeneic ADSC injection for the treatment of
        complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat
        grafts have been the subject of in-depth research. They are popular because it is simple to
        get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in
        adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities.
  
        We would wish to compare the effectiveness of these two injection kinds on perianal fistulas
        as part of our care of CD.
  The trial will be made available to patients who are scheduled for perianal surgery with
        ALOFISEL® or backup (fat injection). The history and signs of perianal fistula will be noted
        if the patient doesn't object.
  
        Two visits that correspond to typical follow-up visits for patients will be noted:
  
        Visit following surgery: fistula clinical evaluation, analgesic use, etc. and six months
        after : clinical assessment, MRI
  observational model: Cohort
  time perspective: Prospective
  measure: Comparing the efficacy of Alofisel treatment versus fat grafting in Crohn's disease complex perianal fistulae
  time frame: 1 month after the surgery
  description: At 1 month, the percentage of healing is defined as the clinical closure of the orifice and the lack of pus draining by pressure on the borders of the fistula scar.
  arm group label: Alofisel group
  description: The patient receives Alofisel injection
  arm group label: Autologous fat injection
  description: The back-up patient receives autologous fat stem cells injection
  intervention type: Drug
  intervention name: Alofisel
  description: Alofisel is made up of 'mesenchymal stem cells' from the fat tissue of a donor. Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease
  arm group label: Alofisel group
  intervention type: Drug
  intervention name: Fat stem cell
  description: mesenchymal stem cells from adipose (fat) tissue injection
  arm group label: Autologous fat injection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Crohn Disease
  mesh term: Rectal Fistula
  mesh term: Fistula