{"id":7865,"date":"2023-06-22T16:14:26","date_gmt":"2023-06-22T14:14:26","guid":{"rendered":"https:\/\/www.icta.fr\/cas-clients\/derived-cell-atmp-implantation-for-the-treatment-of-fecal-incontinence-a-multicentre-randomized-double-blind-placebo-controlled-parallel-group-dose-finding-clinical-study\/"},"modified":"2026-01-14T10:20:24","modified_gmt":"2026-01-14T09:20:24","slug":"derived-cell-atmp-implantation-for-the-treatment-of-fecal-incontinence-a-multicentre-randomized-double-blind-placebo-controlled-parallel-group-dose-finding-clinical-study","status":"publish","type":"casclients","link":"https:\/\/www.icta.fr\/fr\/cas-clients\/derived-cell-atmp-implantation-for-the-treatment-of-fecal-incontinence-a-multicentre-randomized-double-blind-placebo-controlled-parallel-group-dose-finding-clinical-study\/","title":{"rendered":"Derived cell ATMP implantation for the treatment of fecal incontinence: a multicentre, randomized, double-blind, placebo-controlled, parallel-group, dose-finding clinical study."},"content":{"rendered":"\n
<\/div>
\n

OBJECTIVES<\/h3>\n\n\n\n
\n
\n

PRIMARY OBJECTIVES<\/h4>\n\n\n\n

<\/p>\n\n\n\n

    \n
  • Determine change in incontinence episode frequency (IEF) at day 180 from baseline.<\/li>\n<\/ul>\n<\/div>\n\n\n\n
    \n

    SECONDARY OBJECTIVES<\/h4>\n\n\n\n

    <\/p>\n\n\n\n

      \n
    • Evaluate change in the Wexner score<\/li>\n<\/ul>\n\n\n\n
        \n
      • Assess the Visual Analogue Scale<\/li>\n<\/ul>\n\n\n\n
          \n
        • Evaluate anorectal manometry data<\/li>\n\n\n\n
        • Document patient-reported quality of life.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
          \n
          \n

          SCIENTIFIC and DATA VALORISATION<\/h3>\n\n\n\n
            \n
          • Trial results used for the ATMP marketing authorisation and further Phase II design<\/li>\n<\/ul>\n<\/div>\n\n\n\n
            \n

            Key factors of success<\/strong><\/h3>\n\n\n\n
              \n
            • ICTA\u2019s capability to adapt to new regulatory procedure (project started in 2012)<\/li>\n\n\n\n
            • ICTA\u2019s responsiveness and ability to develop adapted IT tool<\/li>\n\n\n\n
            • ICTA\u2019s flexibility to manage additional statistical analyses<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
              \n
              \n

              LESSONS LEARNED to speed up the start-up phase of the next study<\/h3>\n\n\n\n
                \n
              • Importance of close collaboration between ICTA and Sponsor especially in the context of a rescue study<\/li>\n\n\n\n
              • Active involvement of the Sponsor during the study to maintain the centres’ commitment<\/li>\n\n\n\n
              • Optimal project coordination: Timelines, logistics, sub-contractors management, reporting tools implementation, events management.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n

                CHALLENGES<\/h3>\n\n\n\n
                KEY CHALLENGES<\/th>ICTA’s SOLUTIONS<\/th>ICTA’s ACHIEVEMENTS<\/th><\/tr><\/thead>
                Rescue project and<\/strong>
                long delay before Sponsor decides to reactivate the project<\/strong><\/td>                		Pro-active communication with the sponsor on bi-weekly basis during the handover
                Complete quality check of the TMF
                And key study documents to be consistent with trial objectives<\/td>                		Successful project including complete Clinical Study Report (CSR) used to obtain ATMP market approval in Europe<\/td><\/tr>
                ATMP logistics and regulatory procedures<\/strong>
                9 participating countries and 1 laboratory producing the autologous cells<\/td>                		Development of a specific IT tool for a smooth workflow of the ATMP from site to sponsor and sponsor to site.<\/td>3 inspections performed by the Regulatory Authorities in 3 different countries
                \u2794 0 critical finding<\/strong><\/td><\/tr>
                Sites recruitment due to ATMP regulatory procedure to respect<\/strong>
                Product and fecal sample management<\/td>                		Selection of back-up countries
                Assessment of each site facilities and level of staffing to facilitate patient recruitment<\/td>                		99.6% of the originally planned patients were recruited<\/td><\/tr>
                Multiple statistical analyses requested after project re-start<\/strong><\/td>Statistical analysis plan (SAP) check and completed by additional subgroups analyses
                Update of the statistical program<\/td>                		TFLs provided within timelines to Sponsor
                Enabling data valorization within the CSR writing and marketing authorisation dossier<\/td><\/tr>
                <\/td><\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/section>\n\n\n\n
                  \n
                • <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":15,"featured_media":10777,"template":"","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","inline_featured_image":false,"_uag_custom_page_level_css":"","kk_blocks_editor_width":"","_kiokenblocks_attr":"","_kiokenblocks_dimensions":"","footnotes":""},"categories":[],"class_list":["post-7865","casclients","type-casclients","status-publish","has-post-thumbnail","hentry"],"acf":[],"uagb_featured_image_src":{"full":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",850,425,false],"thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence-128x88.jpg",128,88,true],"medium":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence-300x150.jpg",300,150,true],"medium_large":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence-768x384.jpg",768,384,true],"large":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",850,425,false],"1536x1536":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",850,425,false],"2048x2048":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",850,425,false],"post-thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",850,425,false],"wpm_taille_1":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence-364x257.jpg",364,257,true],"wpm_taille_slider":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence-240x145.jpg",240,145,true],"gform-image-choice-sm":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",300,150,false],"gform-image-choice-md":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",400,200,false],"gform-image-choice-lg":["https:\/\/www.icta.fr\/wp-content\/uploads\/fecal-incontinence.jpg",600,300,false]},"uagb_author_info":{"display_name":"Manon ROBERT","author_link":"https:\/\/www.icta.fr\/fr\/author\/mrobert-icta21\/"},"uagb_comment_info":0,"uagb_excerpt":null,"_links":{"self":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/7865","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients"}],"about":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/types\/casclients"}],"author":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/users\/15"}],"version-history":[{"count":8,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/7865\/revisions"}],"predecessor-version":[{"id":8987,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/7865\/revisions\/8987"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media\/10777"}],"wp:attachment":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media?parent=7865"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/categories?post=7865"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}