{"id":28718,"date":"2020-09-05T00:39:08","date_gmt":"2020-09-05T00:39:08","guid":{"rendered":"https:\/\/amelie-project.eu\/?page_id=28718"},"modified":"2026-07-01T09:48:47","modified_gmt":"2026-07-01T09:48:47","slug":"approche","status":"publish","type":"page","link":"https:\/\/amelie-project.eu\/fr\/approche\/","title":{"rendered":"Approche"},"content":{"rendered":"

[et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” disabled_on=”off|off|off” admin_label=”Hero section” _builder_version=”4.16″ background_image=”https:\/\/amelie-project.eu\/wp-content\/uploads\/2020\/10\/AMELIEHEADERBACKGOUND-01-scaled.jpg” background_position=”center_left” custom_margin=”|||” custom_padding=”7%||7%||true|false” custom_padding_tablet=”15%||15%||true|false” custom_padding_phone=”” global_colors_info=”{}”][et_pb_row use_custom_gutter=”on” gutter_width=”1″ custom_padding_last_edited=”on|phone” _builder_version=”4.16″ _module_preset=”default” width=”100%” module_alignment=”left” custom_padding=”|||4%|false|false” custom_padding_tablet=”|||5%|false|false” custom_padding_phone=”|||5.5%|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][dsm_block_reveal_text block_reveal_text=”APPROACH” heading_html_tag=”h1″ block_reveal_color=”#0e94f9″ block_reveal_delay=”0″ _builder_version=”4.16″ _module_preset=”default” header_font=”AMELIE||||||||” header_text_color=”#0e94f9″ header_font_size=”3vw” custom_padding=”||||false|false” custom_padding_tablet=”||||false|false” custom_padding_phone=”||||false|false” custom_padding_last_edited=”on|phone” header_font_size_tablet=”5vw” header_font_size_phone=”6vw” header_font_size_last_edited=”on|phone” global_colors_info=”{}”][\/dsm_block_reveal_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ specialty=”on” padding_top_2=”0px” admin_label=”Course Chapters” _builder_version=”4.16″ custom_margin=”|||” custom_padding=”100px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”2_3″ specialty_columns=”2″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” parallax__hover=”off” parallax_method__hover=”on” custom_padding__hover=”|||”][et_pb_row_inner use_custom_gutter=”on” gutter_width=”4″ _builder_version=”4.16″ custom_margin=”||||false|false” custom_padding=”0px|||” global_colors_info=”{}”][et_pb_column_inner saved_specialty_column_type=”2_3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” parallax__hover=”off” parallax_method__hover=”on” custom_padding__hover=”|||”][et_pb_blurb title=”Project Management and Coordination” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

L'University College London (UCL) assurera la gestion scientifique, contractuelle et financi\u00e8re du projet. Ce r\u00f4le permettra de garantir une coordination efficace des activit\u00e9s, tout en maintenant des normes de qualit\u00e9 \u00e9lev\u00e9es et en veillant \u00e0 ce que les \u00e9tapes cl\u00e9s et les r\u00e9sultats du projet soient atteints dans les d\u00e9lais pr\u00e9vus.<\/p>\n<\/div>\n
Cela inclura \u00e9galement le suivi de la gestion des risques, des consid\u00e9rations \u00e9thiques et des principes d'\u00e9galit\u00e9 entre les femmes et les hommes tout au long du projet.<\/div>\n

[\/et_pb_blurb][et_pb_blurb title=”Cell-microcarrier manufacturing process” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

Dirig\u00e9 par l\u2019Instituto Superior T\u00e9cnico, ce lot de travail visera \u00e0 mettre au point un proc\u00e9d\u00e9 de fabrication robuste, reproductible et \u00e9volutif, conforme aux normes des Bonnes pratiques de fabrication (BPF), pour la fixation de cellules d\u00e9riv\u00e9es du muscle squelettique humain sur des microporteurs issus de la s\u00e9paration de phases induite thermiquement (TIPS). Ce proc\u00e9d\u00e9 standardis\u00e9 sera d\u2019abord v\u00e9rifi\u00e9 par l\u2019University College London avant d\u2019\u00eatre transf\u00e9r\u00e9 au NHS Blood and Transplant, o\u00f9 il fera l\u2019objet d\u2019une validation suppl\u00e9mentaire afin de permettre la fabrication de la th\u00e9rapie combin\u00e9e cellules-microporteurs.<\/span><\/p>\n

[\/et_pb_blurb][et_pb_blurb title=”Manufacture of clinically ready TIPS microcarriers” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

Les microporteurs \u00e0 s\u00e9paration de phases induite thermiquement (TIPS) seront fabriqu\u00e9s \u00e0 l'\u00e9chelle pilote en vue d'une application clinique. L'University College London supervisera les contr\u00f4les visant \u00e0 garantir que les microporteurs r\u00e9pondent \u00e0 toutes les sp\u00e9cifications pr\u00e9d\u00e9finies en mati\u00e8re de qualit\u00e9 et de performances.<\/div>\n
Des \u00e9tudes de stabilit\u00e9 seront men\u00e9es afin d'\u00e9valuer l'int\u00e9grit\u00e9 et les performances \u00e0 long terme du produit implantable compos\u00e9 de cellules et de microporteurs. Parall\u00e8lement, le proc\u00e9d\u00e9 de fabrication fera l'objet d'une \u00e9valuation approfondie afin de d\u00e9terminer s'il se pr\u00eate \u00e0 une mise \u00e0 l'\u00e9chelle et \u00e0 une future production commerciale.<\/div>\n

[\/et_pb_blurb][et_pb_blurb title=”Clinical trial plan and regulatory approval” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

Au cours de la phase de pr\u00e9paration de l'essai, les autorisations r\u00e9glementaires et \u00e9thiques n\u00e9cessaires seront obtenues dans chaque pays participant avant le d\u00e9but du recrutement des patients, sous la coordination g\u00e9n\u00e9rale de l'University College London.<\/div>\n
Cet essai clinique visera \u00e0 d\u00e9terminer si l'implantation d'une th\u00e9rapie \u00e0 base de cellules autologues issues du muscle squelettique et de microporteurs entra\u00eene une r\u00e9duction cliniquement significative de la fr\u00e9quence des \u00e9pisodes d'incontinence f\u00e9cale.<\/div>\n
Les patients, les soignants et le grand public joueront un r\u00f4le actif tout au long du projet, en contribuant \u00e0 la fois \u00e0 la r\u00e9alisation de l'\u00e9tude et \u00e0 la diffusion de ses r\u00e9sultats.<\/div>\n

[\/et_pb_blurb][et_pb_blurb title=”Non-clinical safety studies required for regulatory approval” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

Un programme d'\u00e9tudes de s\u00e9curit\u00e9 non cliniques sera men\u00e9 afin d'\u00e9tayer l'autorisation r\u00e9glementaire de ce traitement. Ces \u00e9tudes permettront de caract\u00e9riser le comportement biologique de la composante cellulaire au sein du produit final et d'\u00e9valuer la r\u00e9ponse tissulaire locale, la persistance et le profil toxicologique du traitement combin\u00e9 cellules-microporteurs, fournissant ainsi les donn\u00e9es n\u00e9cessaires pour d\u00e9montrer son innocuit\u00e9 en vue d'une utilisation clinique.<\/span><\/p>\n

[\/et_pb_blurb][et_pb_blurb title=”Product stability verification” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

Un proc\u00e9d\u00e9 de fabrication robuste et reproductible a \u00e9t\u00e9 mis au point et valid\u00e9 afin de garantir que le produit final puisse \u00eatre pr\u00e9par\u00e9 de mani\u00e8re constante en vue de son stockage et de son transport, tout en pr\u00e9servant sa qualit\u00e9, sa stabilit\u00e9 et son int\u00e9grit\u00e9.<\/span><\/p>\n

[\/et_pb_blurb][et_pb_blurb title=”Collaboration, Dissemination and Stakeholder Engagement” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

Bowel Research UK et PNO Innovation ont men\u00e9 des actions de consultation des parties prenantes tout au long du projet, en collaboration avec des partenaires industriels, des professionnels de sant\u00e9, des patients et le grand public, des associations caritatives, des organisations du secteur tertiaire et la communaut\u00e9 universitaire.<\/div>\n
La collaboration a \u00e9t\u00e9 au c\u0153ur du projet AMELIE. Les membres du consortium continueront \u00e0 travailler en \u00e9troite collaboration avec des partenaires externes afin d'optimiser la diffusion, l'impact et l'exploitation future des travaux de recherche et des r\u00e9sultats du projet.<\/div>\n

[\/et_pb_blurb][et_pb_blurb title=”Knowledge Management and Exploitation” url=”#” icon_placement=”left” image_icon_width=”64px” content_max_width=”1100px” admin_label=”Blurb” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” custom_margin=”||30px||false|false” custom_padding=”30px|40px|30px|40px” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset2″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(10,3,3,0.06)” image_max_width=”64px” locked=”off” global_colors_info=”{}”]<\/p>\n

Ce lot de travail permettra d'\u00e9valuer le potentiel commercial de la technologie des microporteurs cellulaires implantables pour le traitement de l'incontinence f\u00e9cale, tout en identifiant les possibilit\u00e9s d'application de cette plateforme dans d'autres domaines th\u00e9rapeutiques o\u00f9 elle pourrait apporter un b\u00e9n\u00e9fice clinique.<\/span><\/p>\n

[\/et_pb_blurb][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][et_pb_column type=”1_3″ admin_label=”Column” _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” padding_top__hover=”0px” parallax__hover=”off” parallax_method__hover=”on” custom_padding__hover=”|||”][et_pb_blurb title=”Kathryn Pretzel-Shiels” url=”#” image=”https:\/\/amelie-project.eu\/wp-content\/uploads\/2020\/10\/Asset-2.png” image_icon_width=”100px” admin_label=”Instructor” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” text_orientation=”center” custom_margin=”||||false|false” custom_padding=”50px|40px|50px|40px|true|false” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset1″ box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(71,74,182,0.12)” image_max_width=”100px” global_colors_info=”{}”]<\/p>\n

Directeur g\u00e9n\u00e9ral de Bowel Research UK<\/span><\/p>\n

\u201c Vivre avec une incontinence f\u00e9cale peut \u00eatre extr\u00eamement p\u00e9nible et avoir un impact consid\u00e9rable sur la qualit\u00e9 de vie. Comme ce sujet est rarement abord\u00e9 ouvertement, de nombreuses personnes sont \u00e9galement confront\u00e9es \u00e0 la stigmatisation et \u00e0 l\u2019isolement, ce qui rend la situation encore plus difficile \u00e0 g\u00e9rer. La mise au point d\u2019un traitement efficace constituerait non seulement une avanc\u00e9e m\u00e9dicale majeure, mais aussi un changement qui transformerait la vie de millions de personnes. \u201d<\/p>\n

[\/et_pb_blurb][et_pb_blurb title=”Richard Day” url=”#” image=”https:\/\/amelie-project.eu\/wp-content\/uploads\/2020\/10\/Asset-3.png” image_icon_width=”100px” admin_label=”Instructor” _builder_version=”4.16″ header_font=”Gotham kinda bold||||||||” header_text_color=”#000000″ header_line_height=”1.5em” body_font=”Gotham kinda bold||||||||” body_text_color=”#000000″ body_font_size=”16px” body_line_height=”1.9em” background_color=”#ffffff” text_orientation=”center” custom_margin=”||||false|false” custom_padding=”50px|40px|50px|40px|true|false” animation_style=”zoom” animation_direction=”bottom” animation_intensity_zoom=”20%” animation_starting_opacity=”100%” box_shadow_style=”preset1″ box_shadow_vertical=”0px” box_shadow_blur=”60px” box_shadow_color=”rgba(71,74,182,0.12)” image_max_width=”100px” global_colors_info=”{}”]<\/p>\n

Professeur de technologie de m\u00e9decine r\u00e9g\u00e9n\u00e9rative \u00e0 l'University College London
<\/b><\/span><\/p>\n

\u201cNous sommes extr\u00eamement enthousiastes \u00e0 l'id\u00e9e du projet AMELIE et des avantages potentiels qui peuvent d\u00e9couler de la nouvelle approche th\u00e9rapeutique \u00e0 l'\u00e9tude.
Nous sommes impatients de travailler avec le consortium exceptionnel d'universitaires, de cliniciens, d'industriels et d'associations caritatives de toute l'Europe pour d\u00e9velopper notre approche pionni\u00e8re de la m\u00e9decine r\u00e9g\u00e9n\u00e9rative dans le traitement de cette maladie d\u00e9bilitante. Il s'agira d'une approche radicale et innovante qui n'a jamais \u00e9t\u00e9 tent\u00e9e \u00e0 une telle \u00e9chelle.\u201d<\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_section]<\/p>","protected":false},"excerpt":{"rendered":"

\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t
\n\t\t\t\t\t

APPROCHE<\/h1><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>University College London (UCL) will lead the scientific, contractual, and financial management of the project. This role will ensure the effective coordination of activities, maintaining high standards of quality and timely delivery of project milestones and outcomes. It will also include oversight of risk management, ethical considerations, and gender equality principles throughout the project\u2019s duration.Led by Instituto Superior T\u00e9cnico, this work package will develop a robust, reproducible and scalable manufacturing process that complies with Good Manufacturing Practice (GMP) standards for attaching human skeletal muscle-derived cells to thermally induced phase separation (TIPS) microcarriers. The standardised process will first be verified by University College London before being transferred to NHS Blood and Transplant, where it will undergo further validation to support the manufacture of the combined cell\u2013microcarrier therapy.Thermally induced phase separation (TIPS) microcarriers will be manufactured at pilot scale for clinical application. University College London will oversee verification to ensure the microcarriers meet all predefined quality and performance specifications. Stability studies will be undertaken to evaluate the long-term integrity and performance of the implantable cell\u2013microcarrier product. In parallel, the manufacturing process will be comprehensively assessed […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-28718","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/pages\/28718","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/comments?post=28718"}],"version-history":[{"count":28,"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/pages\/28718\/revisions"}],"predecessor-version":[{"id":31766,"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/pages\/28718\/revisions\/31766"}],"wp:attachment":[{"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/media?parent=28718"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}