{"id":358249,"date":"2026-01-20T15:15:43","date_gmt":"2026-01-20T18:15:43","guid":{"rendered":"https:\/\/fdr.com.br\/tendencias\/?p=358249"},"modified":"2026-01-20T15:14:33","modified_gmt":"2026-01-20T18:14:33","slug":"quem-pode-participar-dos-estudos-clinicos-com-polilaminina-criterios-e-locais","status":"publish","type":"post","link":"https:\/\/fdr.com.br\/tendencias\/quem-pode-participar-dos-estudos-clinicos-com-polilaminina-criterios-e-locais\/","title":{"rendered":"Quem pode participar dos estudos cl\u00ednicos com polilaminina? Crit\u00e9rios e locais"},"content":{"rendered":"<p data-start=\"461\" data-end=\"700\">A <strong>Anvisa<\/strong> autorizou, em janeiro de 2026, o in\u00edcio dos estudos cl\u00ednicos com polilaminina para o tratamento de trauma raquimedular agudo. A pesquisa inaugura a fase 1 em humanos e tem como objetivo principal verificar a seguran\u00e7a da prote\u00edna.<\/p>\n<p data-start=\"702\" data-end=\"902\">Atualmente, o projeto ocorre no Brasil e re\u00fane universidades p\u00fablicas, ind\u00fastria farmac\u00eautica e \u00f3rg\u00e3os reguladores. Dessa forma, o pa\u00eds consolida um avan\u00e7o relevante no campo da medicina regenerativa.<\/p>\n<h2 data-start=\"904\" data-end=\"955\">Quem pode participar do estudo com polilaminina?<\/h2>\n<p data-start=\"957\" data-end=\"1150\">A equipe respons\u00e1vel definiu crit\u00e9rios<strong><a href=\"https:\/\/fdr.com.br\/tendencias\/caminhar-apos-os-60-mas-medicos-recomendam\/\"> m\u00e9dicos rigorosos<\/a><\/strong> para selecionar os volunt\u00e1rios. Assim, o protocolo garante maior seguran\u00e7a cl\u00ednica e aumenta a confiabilidade cient\u00edfica dos resultados.<\/p>\n<h3 data-start=\"1152\" data-end=\"1192\">Crit\u00e9rios exigidos para participa\u00e7\u00e3o<\/h3>\n<p data-start=\"1194\" data-end=\"1274\">Podem participar pacientes que atendam simultaneamente aos seguintes requisitos:<\/p>\n<ul data-start=\"1276\" data-end=\"1478\">\n<li data-start=\"1276\" data-end=\"1308\">\n<p data-start=\"1278\" data-end=\"1308\">Idade entre <strong data-start=\"1290\" data-end=\"1306\">18 e 72 anos<\/strong><\/p>\n<\/li>\n<li data-start=\"1309\" data-end=\"1354\">\n<p data-start=\"1311\" data-end=\"1354\">Les\u00e3o medular <strong data-start=\"1325\" data-end=\"1352\">tor\u00e1cica aguda completa<\/strong><\/p>\n<\/li>\n<li data-start=\"1355\" data-end=\"1411\">\n<p data-start=\"1357\" data-end=\"1411\">Localiza\u00e7\u00e3o da les\u00e3o entre as v\u00e9rtebras <strong data-start=\"1397\" data-end=\"1409\">T2 e T10<\/strong><\/p>\n<\/li>\n<li data-start=\"1412\" data-end=\"1478\">\n<p data-start=\"1414\" data-end=\"1478\">Indica\u00e7\u00e3o cir\u00fargica registrada em at\u00e9 <strong data-start=\"1452\" data-end=\"1478\">72 horas ap\u00f3s o trauma<\/strong><\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1480\" data-end=\"1658\">Essas exig\u00eancias, portanto, reduzem varia\u00e7\u00f5es cl\u00ednicas entre os participantes. Com isso, os pesquisadores conseguem observar os efeitos iniciais da subst\u00e2ncia com maior precis\u00e3o.<\/p>\n<style>@media (min-width: 992px) {\n    .recomendadorV2Area1 {\n        width: 280px;\n    }\n    .recomendadorV2Area2 {\n        padding: 0px 20px;\n        width: calc(100% - 280px);\n    }\n}\n\n@media (max-width: 992px) {\n    .recomendadorV2Button {\n        margin: 0 auto;\n    }\n    .recomendadorV2Area {\n        flex-direction: column;\n        text-align: center;\n    }\n    .recomendadorV2Area2 {\n        padding: 0px 20px;\n    }\n}\n\n.recomendadorV2Area {\n    background: #eeeeee3d;\n    border-radius: 10px;\n    padding: 15px;\n    display: flex;\n    margin: 15px auto;\n    border: 1px solid #00000014;\n    max-width: 800px;\n}\n\n.recomendadorV2Area1 img {\n    width: 280px;\n    height: auto;\n    border-radius: 8px;\n}\n\n.linkrecomendadorv2 {\n    text-decoration: none !important;\n}\n\n.recomendadorV2Area2 .recomendadorV2Type {\n    text-transform: uppercase;\n    font-weight: 500;\n    font-size: 11px;\n    letter-spacing: 2px;\n    color: #666;\n    margin: 12px 0;\n    display: block;\n}\n\n.recomendadorV2Title h2 {\n    padding-top: 0px !important;\n    margin: 0px !important;\n    border-left: none !important;\n    padding-left: 0px !important;\n    line-height: 1.3;\n    color: #000 !important;\n    font-size: 24px;\n    margin-bottom: 12px !important;\n}\n\n.recomendadorV2Desc {\n    color: #333;\n    margin: 12px 0px !important;\n    font-size: 15px;\n    line-height: 1.5;\n}\n\n.recomendadorV2Button {\n    width: auto;\n    max-width: 200px;\n    margin: 0;\n    display: inline-flex;\n    align-items: center;\n    background: #1D3557;\n    border-radius: 8px;\n    color: #fff;\n    height: 36px;\n    justify-content: center;\n    text-align: center;\n    font-size: 14px;\n    padding: 0 20px;\n    transition: background-color 0.2s ease;\n}\n\n.recomendadorV2Button:hover {\n    background: #2a4d7a;\n}\n\n.recomendadorV2Button:after {\n    margin-top: -2px;\n    content: \"\u2192\";\n    padding: 0px 0px 0px 8px;\n}\n\n.recomendadorV2Alert {\n    text-align: left;\n    font-size: 11px;\n    margin-top: 8px;\n    color: #666;\n}\n\n.recomendadorFixedArea {\n    width: 100%;\n    display: flex;\n    justify-content: center;\n    align-items: center;\n}\n\n@media (min-width: 992px) {\n    #recomendadorFixed {\n        width: 32% !important;\n        left: 5%;\n    }\n    .recomendadorCloseFixed{\n        right: inherit !important;\n        left: 378px !important;\n    }\n}\n\n#recomendadorFixed {\n    width: 90%;\n    box-shadow: 0 10px 20px 0px #00000057;\n    display: none;\n    height: 90px;\n    background: #F6F6F6;\n    position: fixed;\n    flex-direction: row;\n    bottom: 10px;\n    z-index: 9999;\n    border-radius: 16px;\n    padding: 7px 10px;\n}\n\n.recomendadorLeftArea {\n    width: 160px;\n}\n\n.recomendadorRightArea h2 {\n    padding-top: 0px;\n    margin: 2px 0px 4px 0px !important;\n    font-weight: 400;\n    text-align: center;\n    padding-left: 0px !important;\n    color: #000 !important;\n    border-left: none !important;\n    line-height: 20px;\n    font-size: 12px !important;\n}\n\n.recomendadorImgFixed {\n    overflow: hidden;\n    padding: 8px 6px;\n    height: 100%;\n}\n\n.recomendadorImgFixed img {\n    height: 100% !important;\n    border-radius: 16px;\n}\n\n.recomendadorRightArea {\n    padding-top: 6px;\n    display: flex;\n    width: calc(100% - 130px);\n    justify-content: space-between;\n    align-items: center;\n    flex-direction: column;\n}\n\n.recomendadorButtonFixed {\n    margin: 0 auto;\n    background: #1D3557;\n    width: 80%;\n    text-align: center;\n    font-size: 10px;\n    color: #FFF;\n    padding: 2px 10px;\n    border-radius: 3px;\n}\n\n.recomendadorButtonFixed:after {\n    margin-top: -3px;\n    content: \"\u2192\";\n    padding: 0px 0px 0px 10px;\n}\n\n.recomendadorAlertFixed {\n    font-weight: 400;\n    text-align: center;\n    color: #484848;\n    font-size: 8px;\n}\n\n.recomendadorCloseFixed {\n    z-index: 99999;\n    display: none;\n    right: 0px;\n    left: inherit;\n    bottom: 99px;\n    position: fixed;\n    justify-content: center;\n    background: #F6F6F6;\n    width: 25px;\n    align-items: center;\n    height: 25px;\n    font-weight: 800;\n    border-radius: 50%;\n    border: 1px solid #EBEBEB;\n}\n\n.recomendadorV2Desc{\n    color: #000000;\n    margin: 20px 0px;\n}\n\n@media (max-width: 576px) {\n    .recomendadorV2Area {\n      padding: 10px;\n      max-width: 100%;\n    }\n  \n    .recomendadorV2Area1 img {\n      width: 100%;\n      border-radius: 6px;\n    }\n  \n    .recomendadorV2Area2 .recomendadorV2Type {\n      font-size: 9px;\n      letter-spacing: 1px;\n      margin: 8px 0;\n    }\n  \n    .recomendadorV2Title h2 {\n      font-size: 18px !important;\n      margin-bottom: 8px !important;\n      line-height: 1.2;\n    }\n  \n    .recomendadorV2Desc {\n      font-size: 14px;\n      margin: 8px 0 !important;\n      line-height: 1.4;\n    }\n  \n    .recomendadorV2Button {\n      font-size: 14px;\n      height: 40px;\n      padding: 0 12px;\n      max-width: 100%;\n      width: 100%;\n    }\n  \n    .recomendadorV2Button:after {\n      padding-left: 6px;\n    }\n  }\n  <\/style>\n        <div class=\"lazyblock-recomendador-v2-2jDGz wp-block-lazyblock-recomendador-v2\">\n        <a class=\"linkrecomendadorv2\" href=\"https:\/\/fdr.com.br\/tendencias\/caminhar-apos-os-60-mas-medicos-recomendam\/\">\n            <div class=\"recomendadorV2Area\">\n            <div class=\"recomendadorV2Area1\">\n                <div class=\"recomendadorV2Img\">\n                <img class=\"lazyloaded\" decoding=\"async\" src=\"https:\/\/fdr.com.br\/tendencias\/wp-content\/uploads\/2025\/12\/Exercicio-750x375.jpg\" data-src=\"https:\/\/fdr.com.br\/tendencias\/wp-content\/uploads\/2025\/12\/Exercicio-750x375.jpg\" alt=\"\">\n                <\/div>\n            <\/div>\n            <div class=\"recomendadorV2Area2\">\n                <div class=\"recomendadorV2Type\">\n                    <span>Sa\u00fade e bem-estar<\/span>\n                <\/div>\n                <div class=\"recomendadorV2Title\">\n                <h2><span>Caminhada ap\u00f3s os 60 anos<\/span><\/h2>\n                <\/div>\n                <div class=\"recomendadorV2Desc\">\n                <span>M\u00e9dicos explicam por que caminhar na terceira idade traz tantos benef\u00edcios<\/span>\n                <\/div>\n                <div class=\"recomendadorV2Button\">Entenda melhor<\/div>\n                <div class=\"recomendadorV2Alert\"><\/div>\n            <\/div>\n            <\/div>\n        <\/a>\n        <div>\n            <div style=\"z-index:99999;\" id=\"buttonClose\" onclick=\"closeRecomendadorFixed()\">\n            <div class=\"recomendadorCloseFixed\">X<\/div>\n            <\/div>\n            <a href=\"https:\/\/fdr.com.br\/tendencias\/caminhar-apos-os-60-mas-medicos-recomendam\/\">\n            <div class=\"recomendadorFixedArea\">\n                <div id=\"recomendadorFixed\">\n                <div class=\"recomendadorLeftArea\">\n                    <div class=\"recomendadorImgFixed\">\n                    <img class=\"lazyload\" decoding=\"async\" src=\"https:\/\/fdr.com.br\/tendencias\/wp-content\/uploads\/2025\/12\/Exercicio-750x375.jpg\" alt=\"\">\n                    <\/div>\n                <\/div>\n                <div class=\"recomendadorRightArea\">\n                    <div class=\"recomendadorTitleFixed\">\n                    <h2><span>Caminhada ap\u00f3s os 60 anos<\/span><\/h2>\n                    <\/div>\n                    <div class=\"recomendadorButtonFixed\">Entenda melhor<\/div>\n                    <div class=\"recomendadorAlertFixed\"><\/div>\n                <\/div>\n                <\/div>\n            <\/div>\n            <\/a>\n        <\/div>\n        <\/div>\n<h2 data-start=\"1660\" data-end=\"1701\">Qual \u00e9 o objetivo da fase 1 do estudo?<\/h2>\n<p data-start=\"1703\" data-end=\"1837\">A fase 1 n\u00e3o analisa efic\u00e1cia terap\u00eautica. Seu foco permanece exclusivamente na <strong data-start=\"1783\" data-end=\"1809\">avalia\u00e7\u00e3o de seguran\u00e7a<\/strong> da polilaminina em humanos.<\/p>\n<p data-start=\"1839\" data-end=\"1944\">Os m\u00e9dicos aplicam a prote\u00edna em dose \u00fanica, diretamente no local da les\u00e3o medular, por via intramedular.<\/p>\n<p data-start=\"1946\" data-end=\"1990\">Durante o acompanhamento, a equipe monitora:<\/p>\n<ul data-start=\"1992\" data-end=\"2136\">\n<li data-start=\"1992\" data-end=\"2027\">\n<p data-start=\"1994\" data-end=\"2027\">Eventos adversos leves e graves<\/p>\n<\/li>\n<li data-start=\"2028\" data-end=\"2055\">\n<p data-start=\"2030\" data-end=\"2055\">Respostas inflamat\u00f3rias<\/p>\n<\/li>\n<li data-start=\"2056\" data-end=\"2102\">\n<p data-start=\"2058\" data-end=\"2102\">Forma\u00e7\u00e3o de anticorpos contra a subst\u00e2ncia<\/p>\n<\/li>\n<li data-start=\"2103\" data-end=\"2136\">\n<p data-start=\"2105\" data-end=\"2136\">Altera\u00e7\u00f5es cl\u00ednicas inesperadas<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2138\" data-end=\"2250\">Al\u00e9m disso, a empresa patrocinadora assume toda a responsabilidade pelo monitoramento cl\u00ednico dos participantes.<\/p>\n<h2 data-start=\"2252\" data-end=\"2290\">Quem coordena a pesquisa no Brasil?<\/h2>\n<p data-start=\"2292\" data-end=\"2370\"><strong><a href=\"https:\/\/fdr.com.br\/tendencias\/dengue-e-vacina-quem-deve-tomar-a-dose-unica-e-quais-duvidas-ainda-existem\/\">O estudo avan\u00e7a por meio de coopera\u00e7\u00e3o<\/a><\/strong> entre institui\u00e7\u00f5es p\u00fablicas e privadas:<\/p>\n<ul data-start=\"2372\" data-end=\"2641\">\n<li data-start=\"2372\" data-end=\"2491\">\n<p data-start=\"2374\" data-end=\"2491\"><strong data-start=\"2374\" data-end=\"2401\">Coordena\u00e7\u00e3o cient\u00edfica:<\/strong> Universidade Federal do Rio de Janeiro (UFRJ), liderada pela professora Tatiana Sampaio<\/p>\n<\/li>\n<li data-start=\"2492\" data-end=\"2560\">\n<p data-start=\"2494\" data-end=\"2560\"><strong data-start=\"2494\" data-end=\"2511\">Patrocinador:<\/strong> Crist\u00e1lia Produtos Qu\u00edmicos Farmac\u00eauticos Ltda<\/p>\n<\/li>\n<li data-start=\"2561\" data-end=\"2641\">\n<p data-start=\"2563\" data-end=\"2641\"><strong data-start=\"2563\" data-end=\"2591\">Autoriza\u00e7\u00e3o regulat\u00f3ria:<\/strong> Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa)<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"2643\" data-end=\"2845\">Anteriormente, o Minist\u00e9rio da Sa\u00fade financiou pesquisas b\u00e1sicas sobre a prote\u00edna. Como resultado, os pesquisadores constru\u00edram uma base cient\u00edfica s\u00f3lida que viabilizou a solicita\u00e7\u00e3o do estudo cl\u00ednico.<\/p>\n<h2 data-start=\"2847\" data-end=\"2892\">Onde os estudos cl\u00ednicos ser\u00e3o realizados?<\/h2>\n<p data-start=\"2894\" data-end=\"2969\">A Crist\u00e1lia ainda informar\u00e1 oficialmente \u00e0 Anvisa os centros participantes.<\/p>\n<p data-start=\"2971\" data-end=\"3020\">Entretanto, reportagens j\u00e1 indicam parcerias com:<\/p>\n<ul data-start=\"3022\" data-end=\"3167\">\n<li data-start=\"3022\" data-end=\"3079\">\n<p data-start=\"3024\" data-end=\"3079\">Hospital das Cl\u00ednicas da Faculdade de Medicina da USP<\/p>\n<\/li>\n<li data-start=\"3080\" data-end=\"3123\">\n<p data-start=\"3082\" data-end=\"3123\">Santa Casa de Miseric\u00f3rdia de S\u00e3o Paulo<\/p>\n<\/li>\n<li data-start=\"3124\" data-end=\"3167\">\n<p data-start=\"3126\" data-end=\"3167\">AACD, para etapas futuras de reabilita\u00e7\u00e3o<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"3169\" data-end=\"3284\">Essas institui\u00e7\u00f5es, por sua vez, contam com equipes cir\u00fargicas treinadas para realizar o procedimento experimental.<\/p>\n<h2 data-start=\"3286\" data-end=\"3318\">Quais s\u00e3o as pr\u00f3ximas etapas?<\/h2>\n<p data-start=\"3320\" data-end=\"3395\">Se os dados confirmarem a seguran\u00e7a da subst\u00e2ncia, o projeto avan\u00e7ar\u00e1 para:<\/p>\n<ul data-start=\"3397\" data-end=\"3513\">\n<li data-start=\"3397\" data-end=\"3440\">\n<p data-start=\"3399\" data-end=\"3440\"><strong data-start=\"3399\" data-end=\"3410\">Fase 2:<\/strong> an\u00e1lise inicial de efic\u00e1cia<\/p>\n<\/li>\n<li data-start=\"3441\" data-end=\"3513\">\n<p data-start=\"3443\" data-end=\"3513\"><strong data-start=\"3443\" data-end=\"3454\">Fase 3:<\/strong> amplia\u00e7\u00e3o do n\u00famero de pacientes e defini\u00e7\u00e3o da dose ideal<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"3515\" data-end=\"3619\">Posteriormente, caso os resultados permane\u00e7am positivos, o tratamento poder\u00e1 integrar protocolos do SUS.<\/p>\n<p data-start=\"3621\" data-end=\"3806\">Assim, o avan\u00e7o refor\u00e7a o papel da ci\u00eancia nacional e da<strong><a href=\"https:\/\/fdr.com.br\/tendencias\/sisu-2026-chega-com-novidades-saiba-como-garantir-sua-vaga-no-ensino-superior\/\"> coopera\u00e7\u00e3o entre universidades<\/a><\/strong>, ind\u00fastria farmac\u00eautica e Estado no desenvolvimento de terapias inovadoras para les\u00f5es medulares.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Anvisa autorizou, em janeiro de 2026, o in\u00edcio dos estudos cl\u00ednicos com polilaminina para o tratamento de trauma raquimedular agudo. A pesquisa inaugura a fase 1 em humanos e tem como objetivo principal verificar a seguran\u00e7a da prote\u00edna. Atualmente, o projeto ocorre no Brasil e re\u00fane universidades p\u00fablicas, ind\u00fastria farmac\u00eautica e \u00f3rg\u00e3os reguladores. Dessa [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":358259,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jnews-multi-image_gallery":[],"jnews_single_post":{"format":"standard","override":[{"template":"1","parallax":"1","fullscreen":"1","layout":"right-sidebar","sidebar":"default-sidebar","second_sidebar":"default-sidebar","share_position":"hide","share_float_style":"share-monocrhome","show_share_counter":"1","show_view_counter":"1","show_featured":"1","show_post_meta":"1","show_post_author":"1","show_post_date":"1","post_date_format":"default","post_date_format_custom":"Y\/m\/d","show_post_reading_time":"0","post_reading_time_wpm":"300","post_calculate_word_method":"str_word_count","show_zoom_button":"0","zoom_button_out_step":"2","zoom_button_in_step":"3","show_comment_section":"1","number_popup_post":"1","show_author_box":"1","show_post_related":"0","show_inline_post_related":"0"}],"image_override":[{"single_post_thumbnail_size":"crop-500","single_post_gallery_size":"crop-500"}],"trending_post_position":"meta","trending_post_label":"Trending","sponsored_post_label":"Sponsored by","disable_ad":"0","subtitle":""},"jnews_primary_category":[],"jnews_social_meta":[],"footnotes":""},"categories":[1],"tags":[],"class_list":["post-358249","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-geral"],"_links":{"self":[{"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/posts\/358249","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/comments?post=358249"}],"version-history":[{"count":2,"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/posts\/358249\/revisions"}],"predecessor-version":[{"id":358260,"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/posts\/358249\/revisions\/358260"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/media\/358259"}],"wp:attachment":[{"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/media?parent=358249"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/categories?post=358249"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/fdr.com.br\/tendencias\/wp-json\/wp\/v2\/tags?post=358249"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}