{"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":"tilgang","status":"publish","type":"page","link":"https:\/\/amelie-project.eu\/da\/tilgang\/","title":{"rendered":"Fremgangsm\u00e5de"},"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

University College London (UCL) vil st\u00e5 for den videnskabelige, kontraktm\u00e6ssige og \u00f8konomiske ledelse af projektet. Denne rolle skal sikre en effektiv koordinering af aktiviteterne, opretholdelse af h\u00f8je kvalitetsstandarder samt rettidig gennemf\u00f8relse af projektets milep\u00e6le og resultater.<\/p>\n<\/div>\n
Det vil desuden omfatte tilsyn med risikostyring, etiske overvejelser og principper om ligestilling mellem k\u00f8nnene gennem hele projektets l\u00f8betid.<\/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

Under ledelse af Instituto Superior T\u00e9cnico skal denne arbejdspakke udvikle en robust, reproducerbar og skalerbar fremstillingsproces, der overholder GMP-standarderne (Good Manufacturing Practice) for fastg\u00f8relse af celler fra menneskelige skeletmuskler til TIPS-mikrob\u00e6rere (thermally induced phase separation). Den standardiserede proces vil f\u00f8rst blive verificeret af University College London, inden den overf\u00f8res til NHS Blood and Transplant, hvor den vil gennemg\u00e5 yderligere validering med henblik p\u00e5 at underst\u00f8tte fremstillingen af den kombinerede celle-mikrob\u00e6rer-terapi.<\/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

Mikrob\u00e6rere baseret p\u00e5 termisk induceret faseadskillelse (TIPS) vil blive fremstillet i pilotskala med henblik p\u00e5 klinisk anvendelse. University College London vil st\u00e5 for verifikationen for at sikre, at mikrob\u00e6rerne opfylder alle foruddefinerede kvalitets- og ydeevnespecifikationer.<\/div>\n
Der vil blive gennemf\u00f8rt stabilitetsunders\u00f8gelser for at vurdere det implanterbare celle-mikrob\u00e6rer-produkts integritet og ydeevne p\u00e5 lang sigt. Sidel\u00f8bende hermed vil fremstillingsprocessen blive grundigt vurderet for at fastsl\u00e5, om den er egnet til opskalering og fremtidig kommerciel produktion.<\/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

I l\u00f8bet af fors\u00f8gets forberedelsesfase vil de n\u00f8dvendige myndigheds- og etiske godkendelser blive indhentet i hvert deltagende land, inden rekrutteringen af patienter p\u00e5begyndes, og University College London st\u00e5r for den overordnede koordinering.<\/div>\n
Det kliniske fors\u00f8g skal unders\u00f8ge, om implantation af en terapi baseret p\u00e5 autologe celler fra skeletmuskulaturen p\u00e5 mikrob\u00e6rere f\u00f8rer til en klinisk signifikant reduktion i hyppigheden af episoder med f\u00e6kal inkontinens.<\/div>\n
Patienter, p\u00e5r\u00f8rende og offentligheden vil spille en aktiv rolle gennem hele projektet og bidrage b\u00e5de til gennemf\u00f8relsen af unders\u00f8gelsen og til formidlingen af resultaterne.<\/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

Der vil blive gennemf\u00f8rt et program med ikke-kliniske sikkerhedsunders\u00f8gelser med henblik p\u00e5 at underst\u00f8tte den myndighedsm\u00e6ssige godkendelse af behandlingen. Disse unders\u00f8gelser skal kortl\u00e6gge den biologiske adf\u00e6rd af den cellul\u00e6re komponent i det f\u00e6rdige produkt og vurdere den lokale v\u00e6vsreaktion, persistensen og det toksikologiske profil for den kombinerede celle-mikrob\u00e6rer-behandling, hvilket vil levere den n\u00f8dvendige dokumentation for at p\u00e5vise sikkerheden ved klinisk anvendelse.<\/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

Der er udviklet og valideret en robust og reproducerbar fremstillingsproces for at sikre, at det f\u00e6rdige produkt konsekvent kan klarg\u00f8res til opbevaring og transport, samtidig med at dets kvalitet, stabilitet og integritet bevares.<\/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 og PNO Innovation har st\u00e5et i spidsen for inddragelsen af interessenter gennem hele projektet og har samarbejdet med partnere fra erhvervslivet, sundhedspersonale, patienter og offentligheden, velg\u00f8renhedsorganisationer, organisationer i den tredje sektor samt det akademiske milj\u00f8.<\/div>\n
Samarbejde har v\u00e6ret centralt i AMELIE-projektet. Konsortiets medlemmer vil fortsat arbejde t\u00e6t sammen med eksterne partnere for at sikre st\u00f8rst mulig formidling, gennemslagskraft og fremtidig udnyttelse af projektets forskning og resultater.<\/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

Denne arbejdspakke skal vurdere det kommercielle potentiale i teknologien med implanterbare celle-mikrob\u00e6rere til behandling af f\u00e6kal inkontinens og samtidig identificere muligheder for at anvende platformen inden for andre terapeutiske omr\u00e5der, hvor den kan give klinisk gavn.<\/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

Administrerende direkt\u00f8r hos Bowel Research UK<\/span><\/p>\n

\u201cAt leve med f\u00e6kal inkontinens kan v\u00e6re meget belastende og have en betydelig indvirkning p\u00e5 livskvaliteten. Da emnet sj\u00e6ldent dr\u00f8ftes \u00e5bent, oplever mange mennesker ogs\u00e5 stigmatisering og isolation, hvilket g\u00f8r det endnu sv\u00e6rere at h\u00e5ndtere situationen. At finde en effektiv behandling ville ikke blot v\u00e6re et stort medicinsk gennembrud, men ogs\u00e5 en livsforandrende udvikling for millioner af mennesker.\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

Professor i regenerativ medicinsk teknologi ved University College London
<\/b><\/span><\/p>\n

\u201cVi er enormt begejstrede for udsigten til AMELIE-projektet og de potentielle fordele, der kan opst\u00e5 ved den nye terapeutiske tilgang, der unders\u00f8ges.
Vi ser frem til at arbejde sammen med det enest\u00e5ende konsortium af akademikere, klinikere, industri og velg\u00f8renhedspartnere fra hele Europa for at udvikle vores banebrydende tilgang til regenerativ medicin til behandling af denne invaliderende tilstand. Det vil v\u00e6re en radikal og innovativ tilgang, som aldrig f\u00f8r er fors\u00f8gt i s\u00e5 stor skala.\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

TILGANG<\/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\/da\/wp-json\/wp\/v2\/pages\/28718","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amelie-project.eu\/da\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amelie-project.eu\/da\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amelie-project.eu\/da\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amelie-project.eu\/da\/wp-json\/wp\/v2\/comments?post=28718"}],"version-history":[{"count":28,"href":"https:\/\/amelie-project.eu\/da\/wp-json\/wp\/v2\/pages\/28718\/revisions"}],"predecessor-version":[{"id":31766,"href":"https:\/\/amelie-project.eu\/da\/wp-json\/wp\/v2\/pages\/28718\/revisions\/31766"}],"wp:attachment":[{"href":"https:\/\/amelie-project.eu\/da\/wp-json\/wp\/v2\/media?parent=28718"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}