[et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” disabled_on=”off|off|off” admin_label=”Hero section” _builder_version=”4.6.3″ 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=””][et_pb_row use_custom_gutter=”on” gutter_width=”1″ custom_padding_last_edited=”on|phone” _builder_version=”4.6.3″ _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”][et_pb_column type=”4_4″ _builder_version=”4.6.3″ _module_preset=”default”][dsm_block_reveal_text block_reveal_text=”APPROACH” heading_html_tag=”h1″ block_reveal_color=”#0e94f9″ block_reveal_delay=”0″ _builder_version=”4.6.3″ _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”][\/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=”4.6.3″ custom_margin=”|||” custom_padding=”100px||0px||false|false”][et_pb_column type=”2_3″ specialty_columns=”2″ _builder_version=”3.25″ custom_padding=”|||” parallax__hover=”off” parallax_method__hover=”on” custom_padding__hover=”|||”][et_pb_row_inner use_custom_gutter=”on” gutter_width=”4″ _builder_version=”4.6.3″ custom_margin=”||||false|false” custom_padding=”0px|||”][et_pb_column_inner saved_specialty_column_type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” parallax__hover=”off” parallax_method__hover=”on” custom_padding__hover=”|||”][et_pb_blurb title=”Project Management and Coordination” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.6.3″ 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)” locked=”off”]<\/p>\n
L'UCL sera charg\u00e9e de la gestion scientifique, contractuelle et financi\u00e8re du projet. Cette \u00e9tape du projet garantira la qualit\u00e9 et la rapidit\u00e9 de l'avancement et des r\u00e9sultats du projet, la planification et la gestion des risques, ainsi que la prise en compte des crit\u00e8res \u00e9thiques et des questions d'\u00e9galit\u00e9 entre les hommes et les femmes.<\/p>\n
[\/et_pb_blurb][et_pb_blurb title=”Cell-microcarrier manufacturing process” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.6.3″ 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)” locked=”off”]<\/p>\n
Dirig\u00e9 par l'IST, ce projet \u00e9tablira une proc\u00e9dure robuste, coh\u00e9rente et \u00e9volutive, conforme aux BPF, pour l'attachement de SMDC humains \u00e0 des microporteurs TIPS. Cette proc\u00e9dure normalis\u00e9e sera v\u00e9rifi\u00e9e par l'UCL avant d'\u00eatre transf\u00e9r\u00e9e au NHSBT, o\u00f9 elle sera valid\u00e9e en vue de la fabrication de la combinaison cellule-microporteur.<\/p>\n
[\/et_pb_blurb][et_pb_blurb title=”Manufacture of clinically ready TIPS microcarriers” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.6.3″ 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%” hover_enabled=”0″ 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)” locked=”off” sticky_enabled=”0″]<\/p>\n
Les microporteurs seront fabriqu\u00e9s \u00e0 l'\u00e9chelle pilote. L'UCL supervisera la confirmation que les microporteurs r\u00e9pondent aux sp\u00e9cifications. Les \u00e9tudes de stabilit\u00e9 fourniront des donn\u00e9es sur la stabilit\u00e9 \u00e0 long terme de la combinaison cellule implantable-microporteur. L'\u00e9valuation critique du processus de fabrication \u00e0 ce stade d\u00e9terminera la faisabilit\u00e9 de la mise \u00e0 l'\u00e9chelle du processus pour des quantit\u00e9s commerciales.<\/p>\n
[\/et_pb_blurb][et_pb_blurb title=”Clinical trial plan and regulatory approval” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.6.3″ 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)” locked=”off”]<\/p>\n
Les autorisations r\u00e9glementaires et \u00e9thiques seront demand\u00e9es au cours de la phase de mise en place de l'essai. Chaque pays disposera de toutes les autorisations n\u00e9cessaires avant le recrutement et sera supervis\u00e9 par l'UCL. L'essai clinique testera si l'implantation d'ASMDC-microcarrier conduit \u00e0 une r\u00e9duction minimale cliniquement pertinente de la fr\u00e9quence des \u00e9pisodes d'IF totale. Les patients, les soignants et le public seront impliqu\u00e9s dans la r\u00e9alisation de l'\u00e9tude et la diffusion des r\u00e9sultats.<\/p>\n
[\/et_pb_blurb][et_pb_blurb title=”Non-clinical safety studies required for regulatory approval” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” admin_label=”Chapter” _builder_version=”4.6.3″ 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)” locked=”off”]<\/p>\n
Le comportement biologique attendu du composant cellulaire dans le produit fini sera d\u00e9montr\u00e9 ainsi que la tol\u00e9rance locale, la persistance et les propri\u00e9t\u00e9s toxicologiques de la combinaison cellule-microporteur afin de v\u00e9rifier sa s\u00e9curit\u00e9.<\/p>\n
[\/et_pb_blurb][et_pb_blurb title=”Verification of product stability” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” _builder_version=”4.6.3″ 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)” locked=”off”]<\/p>\n
Un processus robuste et coh\u00e9rent de pr\u00e9paration du produit fini dans un \u00e9tat adapt\u00e9 au stockage et au transport sera con\u00e7u et valid\u00e9.<\/p>\n
[\/et_pb_blurb][et_pb_blurb title=”Dissemination and Stakeholder Engagement” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” _builder_version=”4.6.3″ 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)” locked=”off”]<\/p>\n
Bowel Research UK et TT travailleront ensemble avec tous les b\u00e9n\u00e9ficiaires d'AMELIE pour s'engager aupr\u00e8s des entreprises et des b\u00e9n\u00e9ficiaires industriels, des professionnels de la sant\u00e9, des patients et du public, des organisations caritatives et du troisi\u00e8me secteur, ainsi que des universitaires.<\/p>\n
[\/et_pb_blurb][et_pb_blurb title=”Knowledge Management and Exploitation” url=”#” icon_placement=”left” image_max_width=”64px” content_max_width=”1100px” admin_label=”Blurb” _builder_version=”4.6.3″ 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)” locked=”off”]<\/p>\n
Ce paquet cherchera \u00e0 comprendre le bien-fond\u00e9 et la base d'un dossier commercial pour l'application de la technologie des microporteurs cellulaires implantables dans le traitement de la FI et \u00e0 explorer d'autres march\u00e9s potentiels o\u00f9 la technologie pourrait \u00e9galement \u00eatre utilis\u00e9e de mani\u00e8re efficace.<\/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=”3.25″ custom_padding=”|||” padding_top__hover=”0px” parallax__hover=”off” parallax_method__hover=”on” custom_padding__hover=”|||”][et_pb_blurb title=”Lesley Booth” url=”#” image=”https:\/\/amelie-project.eu\/wp-content\/uploads\/2020\/10\/Asset-2.png” image_max_width=”100px” admin_label=”Instructor” _builder_version=”4.6.3″ 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)”]<\/p>\n
MBE, directeur de la recherche et du PPIE \u00e0 Bowel Research UK<\/span><\/p>\n \u201cLa r\u00e9alit\u00e9 de l'incontinence f\u00e9cale peut \u00eatre d\u00e9vastatrice. Elle limite d\u00e9finitivement l'esp\u00e9rance de vie. Et le fait qu'il s'agisse d'une maladie dont les gens ne parlent pas librement ne fait qu'ajouter aux difficult\u00e9s de mener une vie normale. La d\u00e9couverte d'une th\u00e9rapie efficace ne serait pas seulement une avanc\u00e9e m\u00e9dicale majeure, elle changerait la vie de millions de personnes\u201d.\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_max_width=”100px” admin_label=”Instructor” _builder_version=”4.6.3″ 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)”]<\/p>\n Professeur de technologie de m\u00e9decine r\u00e9g\u00e9n\u00e9rative \u00e0 l'University College London \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. [\/et_pb_blurb][\/et_pb_column][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.6.3″ _module_preset=”default”][\/et_pb_section]<\/p>","protected":false},"excerpt":{"rendered":"
<\/b><\/span><\/p>\n
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>\nAPPROCHE<\/h1><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>UCL will be in charge of the scientific, contractual and financial management of the project. This stage of the project will ensure proper quality and timeliness of project progress and results, address risk planning and management as well as considering ethical criteria and gender issues.Led by IST, this will establish a robust, consistent and scalable GMP compliant procedure for attachment of human SMDC to TIPS microcarriers. This standardised procedure will be verified by UCL before being transferred to NHSBT, where the process will be validated in readiness for manufacture of the cell-microcarrier combination.The microcarriers will be manufactured at pilot scale. UCL will oversee confirmation that the microcarriers meet specifications. Stability studies will provide data on the long-term stability of the implantable cell-microcarrier combination. Critical evaluation of the manufacturing process at this stage will determine the feasibility of scaling-up the process for commercial quantities. Regulatory and Ethical approvals will be sought in the set-up phase of the trial. Each country will have all relevant approvals in place prior to recruitment and will be overseen by UCL. The clinical trial will test whether ASMDC-microcarrier implantation leads […]<\/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":23,"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/pages\/28718\/revisions"}],"predecessor-version":[{"id":31220,"href":"https:\/\/amelie-project.eu\/fr\/wp-json\/wp\/v2\/pages\/28718\/revisions\/31220"}],"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}]}}