{"id":3246,"date":"2022-09-14T09:34:30","date_gmt":"2022-09-14T07:34:30","guid":{"rendered":"https:\/\/hemerapharma.com\/studi-clinici\/"},"modified":"2026-01-19T19:55:19","modified_gmt":"2026-01-19T18:55:19","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/hemerapharma.com\/en\/clinical-trials\/","title":{"rendered":"Clinical trials"},"content":{"rendered":"

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The value of an idea lies in the using of it ~ Thomas\u00a0<\/span>Edison<\/p>\n

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Clinical development<\/h2>\n

After completing the preclinical validation phase, REMAST therapy<\/a> enters in the clinical path<\/strong>.<\/p>\n

Hemera’s goal is to start the Clinical Trial within 2027<\/strong>.<\/p>\n

To this end, Hemera\u2019s scientists will work to address two main fronts: the production of the cell therapy<\/strong> according to the high pharmaceutical quality standards and the approval of protocols<\/strong> for the first applications of the therapy in humans.<\/p>\n

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2023<\/b><\/h3>\n

<\/b><\/p>\n

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In 2023<\/strong>, a prospective observational study<\/strong> of patients with complete traumatic spinal cord injury began..<\/p>\n

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The aim of the study is to monitor the clinical trend of motor, sensory and physiological functions<\/strong> in spinal cord-injured patients, starting from the acute post-traumatic phase, and to validate the criteria for inclusion of patients in the subsequent interventional study.<\/p>\n

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2024-2025<\/h4>\n

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The team works on defining the production protocols for Hemera\u2019s advanced cell therapy at a pharmaceutical-grade level<\/strong>, in accordance with standardized criteria of safety, quality, efficacy, and reproducibility<\/strong> required by Regulatory Agencies<\/strong> for the clinical use of drugs in humans. This will enable us to obtain the necessary authorizations to launch the multicenter Phase 1\u20132 first-in-human<\/em><\/strong> clinical trial at selected centers of excellence in Italy and Europe.<\/p>\n

At the same time, the team is actively developing the REMaST platform for new applications in the field of regenerative medicine.<\/strong><\/p>\n

\u200b<\/p>\n

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2026-2027<\/b><\/h3>\n

 <\/p>\n

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Hemera completes the key regulatory documentation<\/strong> required to start the REMaST\u00ae clinical trial. This includes the Investigator\u2019s Brochure (IB), the Investigational Medicinal Product Dossier (IMPD)<\/strong>, and the interventional clinical protocol<\/strong>, consolidating preclinical, safety, and GMP manufacturing data.<\/p>\n

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Building on the Orphan Drug Designation<\/em> granted by the EMA, Hemera strengthens its engagement with European regulatory authorities through targeted Scientific Advice into an early and continuous dialogue\u00a0 to optimize the clinical development strategy, align on product and protocol requirements, and benefit from accelerated regulatory pathways for innovative therapies addressing high unmet medical needs<\/strong>.<\/p>\n

Hemera actively engages in developing an international clinical network<\/strong> with centers of excellence for the treatment of spinal cord injuries, and in developing\u00a0a customized catheter-based delivery system.<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”About” _builder_version=”4.18.1″ _module_preset=”default” background_color=”#eaeaea” background_image=”https:\/\/hemerapharma.com\/wp-content\/uploads\/2022\/09\/e-sfondo.png” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”4.18.1″ _module_preset=”default” background_enable_color=”off” transform_translate=”1px|0px” transform_translate_linked=”off” animation_style=”flip” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.18.1″ _module_preset=”default” border_width_right=”1px” border_color_right=”#FFFFFF” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.5″ _module_preset=”1f09816e-184e-4ce5-a4cf-b39c52c423ca” header_font_size=”46px” header_letter_spacing=”-0.02em” header_line_height=”1.15em” header_2_text_align=”left” header_2_text_color=”#333333″ header_2_font_size=”45px” header_2_line_height=”1.2em” header_3_font_size=”45px” custom_margin=”||||false|false” custom_padding=”|6px||||” custom_padding_tablet=”|0%|0%||false|false” custom_padding_phone=”|0%|0%||false|false” custom_padding_last_edited=”on|phone” animation_style=”fade” hover_enabled=”0″ text_font_size_tablet=”” text_font_size_phone=”” text_font_size_last_edited=”on|phone” header_font_size_tablet=”38px” header_font_size_phone=”24px” header_font_size_last_edited=”on|desktop” header_2_text_align_tablet=”center” header_2_text_align_phone=”center” header_2_text_align_last_edited=”on|tablet” header_2_font_size_tablet=”37px” header_2_font_size_phone=”30px” header_2_font_size_last_edited=”on|phone” header_3_text_color_tablet=”” header_3_text_color_phone=”” header_3_text_color_last_edited=”on|tablet” text_orientation_tablet=”center” text_orientation_phone=”center” text_orientation_last_edited=”on|tablet” border_color_right=”#FFFFFF” border_width_bottom_tablet=”0px” border_width_bottom_phone=”0px” border_width_bottom_last_edited=”on|tablet” locked=”off” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

Phase 1<\/strong> of the clinical trial begins in collaboration with the selected CRO<\/h3>\n

which oversees patient monitoring and efficacy data collection over 12 months period. The trial, conducted at Niguarda Hospital in Milan,<\/strong> involves an initial group of 6 patients, leveraging the Orphan Drug Designation<\/em> obtained in 2023.<\/p>\n

The goal of the first-in-human<\/em> interventional clinical trial<\/strong> is to demonstrate the safety<\/strong> and efficacy<\/strong> of the REMaST\u00ae therapy, while defining the optimal dose and route of administration<\/strong>.<\/p>\n

If results are positive, Hemera may gain access to the EMA\u2019s accelerated approval pathway (PRIority MEdicines \u2013 PRIME Programme)<\/a> <\/strong>and will work on defining the pricing and market access strategy in coordination with national and international regulatory authorities.<\/p>\n

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2028-2029<\/h4>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ disabled_on=”off|off|off” admin_label=”CTA Section” _builder_version=”4.18.0″ background_color=”#00a8b4″ custom_padding=”28px||28px|” animation_style=”fade” saved_tabs=”all” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”3_4,1_4″ use_custom_gutter=”on” make_equal=”on” admin_label=”CTA Area” _builder_version=”4.18.0″ custom_margin=”||1%||false|false” custom_padding=”0px||0px|” global_colors_info=”{}”][et_pb_column type=”3_4″ module_class=”iq-centra-verticale” _builder_version=”4.18.0″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”|700|||||||” text_font_size=”30px” text_line_height=”1.4em” header_text_align=”center” header_2_font_size=”38px” header_3_text_align=”center” text_orientation=”center” background_layout=”dark” module_alignment=”center” custom_margin=”||||false|false” text_font_size_tablet=”28px” text_font_size_phone=”26px” text_font_size_last_edited=”on|phone” header_3_font_size_tablet=”25px” header_3_font_size_phone=”20px” header_3_font_size_last_edited=”on|tablet” locked=”off” global_colors_info=”{}”]<\/p>\n

Stay informed on Hemera’s latest activities with our Newsletter.<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_button button_url=”https:\/\/hemerapharma.com\/en\/newsletter-en” button_text=”Subscribe” button_alignment=”center” button_alignment_tablet=”center” button_alignment_phone=”center” button_alignment_last_edited=”on|phone” _builder_version=”4.25.2″ _module_preset=”default” custom_button=”on” button_text_color=”#000000″ button_bg_color=”#fdc82f” button_border_width=”0px” button_border_radius=”100px” button_font=”Sarabun|600|||||||” background_layout=”dark” custom_padding=”15px|52px|15px|52px|true|true” animation_style=”slide” locked=”off” global_colors_info=”{}” button_bg_color__hover_enabled=”on|desktop” button_bg_color__hover=”#fdc82f”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

The value of an idea lies in the using of it ~ Thomas\u00a0EdisonClinical development After completing the preclinical validation phase, REMAST therapy enters in the clinical path. Hemera’s goal is to start the Clinical Trial within 2027. To this end, Hemera\u2019s scientists will work to address two main fronts: the production of the cell therapy […]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-3246","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/pages\/3246","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/comments?post=3246"}],"version-history":[{"count":19,"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/pages\/3246\/revisions"}],"predecessor-version":[{"id":6596,"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/pages\/3246\/revisions\/6596"}],"wp:attachment":[{"href":"https:\/\/hemerapharma.com\/en\/wp-json\/wp\/v2\/media?parent=3246"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}