[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
A UCL ser\u00e1 respons\u00e1vel pela gest\u00e3o cient\u00edfica, contratual e financeira do projeto. Esta fase do projeto assegurar\u00e1 a qualidade adequada e a pontualidade dos progressos e resultados do projeto, abordar\u00e1 o planeamento e a gest\u00e3o dos riscos e ter\u00e1 em conta crit\u00e9rios \u00e9ticos e quest\u00f5es de g\u00e9nero.<\/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
Liderado pelo IST, este projeto estabelecer\u00e1 um procedimento robusto, consistente e escal\u00e1vel, em conformidade com as BPF, para a fixa\u00e7\u00e3o de SMDC humanas em microtransportadores TIPS. Este procedimento normalizado ser\u00e1 verificado pela UCL antes de ser transferido para o NHSBT, onde o processo ser\u00e1 validado em prepara\u00e7\u00e3o para o fabrico da combina\u00e7\u00e3o c\u00e9lula-microtransportador.<\/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
Os microtransportadores ser\u00e3o fabricados \u00e0 escala-piloto. A UCL supervisionar\u00e1 a confirma\u00e7\u00e3o de que os microtransportadores cumprem as especifica\u00e7\u00f5es. Os estudos de estabilidade fornecer\u00e3o dados sobre a estabilidade a longo prazo da combina\u00e7\u00e3o implant\u00e1vel c\u00e9lula-microtransportador. A avalia\u00e7\u00e3o cr\u00edtica do processo de fabrico nesta fase determinar\u00e1 a viabilidade do aumento de escala do processo para quantidades comerciais.<\/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
As aprova\u00e7\u00f5es regulamentares e \u00e9ticas ser\u00e3o obtidas na fase de prepara\u00e7\u00e3o do ensaio. Cada pa\u00eds ter\u00e1 todas as aprova\u00e7\u00f5es relevantes em vigor antes do recrutamento e ser\u00e1 supervisionado pela UCL. O ensaio cl\u00ednico ir\u00e1 testar se a implanta\u00e7\u00e3o de microportadores ASMDC conduz a uma redu\u00e7\u00e3o m\u00ednima clinicamente relevante da frequ\u00eancia dos epis\u00f3dios totais de FI. Os doentes, os prestadores de cuidados e o p\u00fablico em geral ser\u00e3o envolvidos na realiza\u00e7\u00e3o do estudo e na divulga\u00e7\u00e3o dos resultados.<\/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
O comportamento biol\u00f3gico esperado do componente celular no produto acabado ser\u00e1 demonstrado juntamente com a toler\u00e2ncia local, a persist\u00eancia e as propriedades toxicol\u00f3gicas da combina\u00e7\u00e3o c\u00e9lula-microtransportador, a fim de verificar a sua seguran\u00e7a.<\/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
Ser\u00e1 concebido e validado um processo robusto e coerente para preparar o produto acabado num estado adequado para armazenamento e transporte.<\/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
A Bowel Research UK e a TT trabalhar\u00e3o em conjunto com todos os benefici\u00e1rios do programa AMELIE para colaborar com as empresas e os benefici\u00e1rios industriais, os profissionais de sa\u00fade, os doentes e o p\u00fablico, as institui\u00e7\u00f5es de caridade e o terceiro sector e os acad\u00e9micos.<\/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
Este pacote procurar\u00e1 compreender o m\u00e9rito e a base de uma justifica\u00e7\u00e3o comercial para a aplica\u00e7\u00e3o da tecnologia de microtransportadores celulares implant\u00e1veis no tratamento da IF e explorar outros mercados potenciais em que a tecnologia possa tamb\u00e9m ser eficazmente utilizada.<\/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, Diretor de Investiga\u00e7\u00e3o e PPIE na Bowel Research UK<\/span><\/p>\n \u201cA realidade de viver com incontin\u00eancia fecal pode ser devastadora. \u00c9 definitivamente uma limita\u00e7\u00e3o de vida. E o facto de ser uma doen\u00e7a que as pessoas n\u00e3o discutem livremente s\u00f3 aumenta as dificuldades de levar uma vida normal. Encontrar uma terapia que funcione n\u00e3o seria apenas um grande avan\u00e7o m\u00e9dico, seria uma mudan\u00e7a de vida para milh\u00f5es de pessoas\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 Professor de Tecnologia de Medicina Regenerativa na University College London \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. [\/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
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>\nABORDAGEM<\/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\/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":23,"href":"https:\/\/amelie-project.eu\/pt\/wp-json\/wp\/v2\/pages\/28718\/revisions"}],"predecessor-version":[{"id":31220,"href":"https:\/\/amelie-project.eu\/pt\/wp-json\/wp\/v2\/pages\/28718\/revisions\/31220"}],"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}]}}