{"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":"abordagem","status":"publish","type":"page","link":"https:\/\/amelie-project.eu\/pt\/abordagem\/","title":{"rendered":"Abordagem"},"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

A University College London (UCL) ir\u00e1 liderar a gest\u00e3o cient\u00edfica, contratual e financeira do projeto. Esta fun\u00e7\u00e3o garantir\u00e1 a coordena\u00e7\u00e3o eficaz das atividades, mantendo elevados padr\u00f5es de qualidade e assegurando o cumprimento atempado das etapas e dos resultados do projeto.<\/p>\n<\/div>\n
Incluir\u00e1 ainda a supervis\u00e3o da gest\u00e3o de riscos, das considera\u00e7\u00f5es \u00e9ticas e dos princ\u00edpios de igualdade de g\u00e9nero ao longo de toda a dura\u00e7\u00e3o do projeto.<\/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

Liderado pelo Instituto Superior T\u00e9cnico, este pacote de trabalho ir\u00e1 desenvolver um processo de fabrico robusto, reprodut\u00edvel e escal\u00e1vel, em conformidade com as normas das Boas Pr\u00e1ticas de Fabrico (BPF), para a fixa\u00e7\u00e3o de c\u00e9lulas derivadas do m\u00fasculo esquel\u00e9tico humano em microportadores de separa\u00e7\u00e3o de fases induzida termicamente (TIPS). O processo padronizado ser\u00e1 primeiro verificado pela University College London antes de ser transferido para o NHS Blood and Transplant, onde ser\u00e1 submetido a uma valida\u00e7\u00e3o adicional para apoiar o fabrico da terapia combinada de c\u00e9lulas e microportadores.<\/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

As microportadoras de separa\u00e7\u00e3o de fases induzida termicamente (TIPS) ser\u00e3o fabricadas em escala-piloto para aplica\u00e7\u00e3o cl\u00ednica. A University College London supervisionar\u00e1 a verifica\u00e7\u00e3o para garantir que as microportadoras cumprem todas as especifica\u00e7\u00f5es de qualidade e desempenho predefinidas.<\/div>\n
Ser\u00e3o realizados estudos de estabilidade para avaliar a integridade e o desempenho a longo prazo do produto implant\u00e1vel composto por c\u00e9lulas e microportadores. Paralelamente, o processo de fabrico ser\u00e1 avaliado de forma exaustiva para determinar a sua adequa\u00e7\u00e3o ao aumento de escala e \u00e0 futura produ\u00e7\u00e3o comercial.<\/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

Durante a fase de prepara\u00e7\u00e3o do ensaio cl\u00ednico, ser\u00e3o obtidas as aprova\u00e7\u00f5es regulamentares e \u00e9ticas necess\u00e1rias em cada pa\u00eds participante antes do in\u00edcio do recrutamento de doentes, sendo a coordena\u00e7\u00e3o geral assegurada pela University College London.<\/div>\n
O ensaio cl\u00ednico ir\u00e1 avaliar se a implanta\u00e7\u00e3o de uma terapia \u00e0 base de c\u00e9lulas aut\u00f3logas derivadas do m\u00fasculo esquel\u00e9tico e microportadoras conduz a uma redu\u00e7\u00e3o clinicamente significativa da frequ\u00eancia dos epis\u00f3dios de incontin\u00eancia fecal.<\/div>\n
Os doentes, os cuidadores e o p\u00fablico em geral desempenhar\u00e3o um papel ativo ao longo de todo o projeto, contribuindo tanto para a realiza\u00e7\u00e3o do estudo como para a divulga\u00e7\u00e3o dos seus resultados.<\/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

Ser\u00e1 realizado um programa de estudos de seguran\u00e7a n\u00e3o cl\u00ednicos para apoiar a aprova\u00e7\u00e3o regulamentar da terapia. Estes estudos ir\u00e3o caracterizar o comportamento biol\u00f3gico do componente celular no produto final e avaliar a resposta tecidular local, a persist\u00eancia e o perfil toxicol\u00f3gico da terapia combinada de c\u00e9lulas e microportadores, fornecendo as evid\u00eancias necess\u00e1rias para demonstrar a sua seguran\u00e7a para utiliza\u00e7\u00e3o cl\u00ednica.<\/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

Foi desenvolvido e validado um processo de fabrico robusto e reprodut\u00edvel, com o objetivo de garantir que o produto final possa ser preparado de forma consistente para armazenamento e transporte, mantendo a sua qualidade, estabilidade e integridade.<\/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

A Bowel Research UK e a PNO Innovation lideraram as atividades de envolvimento das partes interessadas ao longo de todo o projeto, trabalhando com parceiros do setor, profissionais de sa\u00fade, doentes e o p\u00fablico em geral, institui\u00e7\u00f5es de caridade, organiza\u00e7\u00f5es do terceiro setor e a comunidade acad\u00e9mica.<\/div>\n
A colabora\u00e7\u00e3o tem sido fundamental para o projeto AMELIE. Os membros do cons\u00f3rcio continuar\u00e3o a trabalhar em estreita colabora\u00e7\u00e3o com parceiros externos para maximizar a divulga\u00e7\u00e3o, o impacto e a futura explora\u00e7\u00e3o da investiga\u00e7\u00e3o e dos resultados do projeto<\/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

Este pacote de trabalho ir\u00e1 avaliar o potencial comercial da tecnologia de microportadores celulares implant\u00e1veis para o tratamento da incontin\u00eancia fecal, identificando simultaneamente oportunidades para aplicar a plataforma noutras \u00e1reas terap\u00eauticas onde possa proporcionar benef\u00edcios cl\u00ednicos.<\/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

Diretor Executivo da Bowel Research UK<\/span><\/p>\n

\u201cViver com incontin\u00eancia fecal pode ser extremamente angustiante e ter um impacto profundo na qualidade de vida. Como raramente se fala abertamente sobre o assunto, muitas pessoas enfrentam tamb\u00e9m o estigma e o isolamento, o que torna ainda mais dif\u00edcil lidar com a situa\u00e7\u00e3o. Encontrar um tratamento eficaz representaria n\u00e3o s\u00f3 um grande avan\u00e7o m\u00e9dico, mas tamb\u00e9m uma mudan\u00e7a que transformaria a vida de milh\u00f5es de pessoas.\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 de Tecnologia de Medicina Regenerativa na University College London
<\/b><\/span><\/p>\n

\u201cEstamos extremamente entusiasmados com a perspetiva do projeto AMELIE e com os potenciais benef\u00edcios que podem advir da nova abordagem terap\u00eautica que est\u00e1 a ser investigada.
Aguardamos com expetativa a oportunidade de trabalhar com o excecional cons\u00f3rcio de acad\u00e9micos, cl\u00ednicos, ind\u00fastria e parceiros de caridade de toda a Europa para desenvolver a nossa abordagem pioneira de medicina regenerativa para o tratamento desta doen\u00e7a debilitante. Esta ser\u00e1 uma abordagem radical e inovadora, nunca antes tentada a esta escala\u201d.\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":"

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