{"id":16972,"date":"2025-05-05T10:46:49","date_gmt":"2025-05-05T08:46:49","guid":{"rendered":"https:\/\/www.bm-t.de\/2023-en\/bioncart-erhaelt-genehmigung-zur-klinischen-studie\/"},"modified":"2025-05-05T10:53:43","modified_gmt":"2025-05-05T08:53:43","slug":"bioncart-erhaelt-genehmigung-zur-klinischen-studie","status":"publish","type":"post","link":"https:\/\/www.bm-t.de\/en\/2025-en\/bioncart-erhaelt-genehmigung-zur-klinischen-studie\/","title":{"rendered":"BIONCaRT receives approval to conduct a clinical trial with stem cells for the treatment of cartilage damage in the knee&nbsp;joint"},"content":{"rendered":"<p>BION\u00adCaRT GmbH has received approval to con\u00adduct a clin\u00adi\u00adcal phase I\/IIa study from the respon\u00adsi\u00adble national higher fed\u00aderal author\u00adity, the Paul Ehrlich Insti\u00adtute. The aim of the study is to inves\u00adti\u00adgate the safety and ini\u00adtial indi\u00adca\u00adtions of the effi\u00adcacy of mes\u00adenchy\u00admal stro\u00admal cells obtained from umbil\u00adi\u00adcal cord tis\u00adsue for the treat\u00adment of car\u00adti\u00adlage dam\u00adage in the knee&nbsp;joint.<\/p>\n<p>The clin\u00adi\u00adcal trial in accor\u00addance with the Ger\u00adman Drug Law is enti\u00adtled: \u201cPhase I\/IIa study to test the safety and effi\u00adcacy of MSC from umbil\u00adi\u00adcal cord tis\u00adsue (UC-MSC) for the treat\u00adment of car\u00adti\u00adlage dam\u00adage in the knee&nbsp;joint\u201d.<\/p>\n<p>BION\u00adCaRT will con\u00adduct the study over the com\u00ading months in close col\u00adlab\u00ado\u00adra\u00adtion with eight renowned clin\u00adics as test cen\u00adters as well as the part\u00adner insti\u00adtu\u00adtions Fraun\u00adhofer Insti\u00adtute for Cell Ther\u00adapy and Immunol\u00adogy (IZI), which is respon\u00adsi\u00adble for pro\u00adduc\u00ading the clin\u00adi\u00adcal test sam\u00adples under GMP, Pol\u00adski Bank Kom\u00f3rek Macierzystych (PBKM) and the Coor\u00addi\u00adna\u00adtion Cen\u00adter for Clin\u00adi\u00adcal Stud\u00adies (KKS) Dres\u00adden at TU Dres\u00adden. Prof. Dr. med. J\u00f6rg L\u00fctzner, Uni\u00adver\u00adsity Cen\u00adter for Orthopaedics, Trauma &amp; Plas\u00adtic Surgery, Carl Gus\u00adtav Carus Uni\u00adver\u00adsity Hos\u00adpi\u00adtal, TU Dres\u00adden, will lead the&nbsp;study.<\/p>\n<p>\u201cThe approval of this study is a sig\u00adnif\u00adi\u00adcant mile\u00adstone for BION\u00adCaRT and our part\u00adners. It brings us closer to our goal of pro\u00advid\u00ading all patients of all ages with access to cell-based regen\u00ader\u00ada\u00adtive ther\u00ada\u00adpies,\u201d says Dr. Andr\u00e9 Gerth, CEO of BION\u00adCaRT. \u201cWe would like to thank the reg\u00adu\u00adla\u00adtory author\u00adity for their trust and our part\u00adners for their com\u00admit\u00adted and com\u00adpe\u00adtent cooperation.\u201d<\/p>\n<p>This study is another impor\u00adtant step for BION\u00adCaRT on the path to clin\u00adi\u00adcal trans\u00adla\u00adtion of inno\u00adv\u00ada\u00adtive cell-based ther\u00ada\u00adpies. The results of the Phase I\/IIa trial will be deci\u00adsive for the fur\u00adther devel\u00adop\u00adment pro\u00adgram and the approval process.<\/p>\n<p>\u201cAs a local ven\u00adture cap\u00adi\u00adtal\u00adist, we are delighted to be able to sup\u00adport BION\u00adCaRT, a Cen\u00adtral Ger\u00adman life sci\u00adence com\u00adpany, on its path to clin\u00adi\u00adcal trans\u00adla\u00adtion. The study that has now been launched is an impor\u00adtant step for the devel\u00adop\u00adment of novel, cell-based ther\u00ada\u00adpies and at the same time strength\u00adens Sax\u00adony and Thuringia as a biotech\u00adnol\u00adogy loca\u00adtion.\u201d \u2014 <a href=\"\/?p=1945\">Katja Butz\u00admann<\/a>, Man\u00adag\u00ading Direc\u00adtor, bm|t Beteili\u00adgungs\u00adman\u00adage\u00adment Th\u00fcrin\u00adgen GmbH &amp; Oliver Latz, Senior Invest\u00adment Man\u00adager, TGFS Tech\u00adnolo\u00adgiegr\u00fcn\u00adder\u00adfonds Sachsen<\/p>\n<h4><strong>About BIONCaRT<\/strong><\/h4>\n<p>As a research-based phar\u00adma\u00adceu\u00adti\u00adcal com\u00adpany, <a href=\"https:\/\/bioncart.com\">BION\u00adCaRT<\/a> focuses on the devel\u00adop\u00adment of cell ther\u00adapy drugs for clin\u00adi\u00adcal use in humans, par\u00adtic\u00adu\u00adlarly for the treat\u00adment of orthopaedic dis\u00adeases. The focus is pri\u00admar\u00adily on allo\u00adgeneic ther\u00adapy con\u00adcepts. The com\u00adpa\u00adny\u2019s main focus is on the devel\u00adop\u00adment, approval and man\u00adu\u00adfac\u00adture of stem cell-based drug products.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BION\u00adCaRT GmbH has received approval to con\u00adduct a clin\u00adi\u00adcal phase I\/IIa study from the respon\u00adsi\u00adble national higher fed\u00aderal author\u00adity, the Paul Ehrlich Insti\u00adtute. The aim of the study is to inves\u00adti\u00adgate the safety and ini\u00adtial indi\u00adca\u00adtions of the effi\u00adcacy of mes\u00adenchy\u00admal stro\u00admal cells obtained from umbil\u00adi\u00adcal cord tis\u00adsue for the treat\u00adment of car\u00adti\u00adlage dam\u00adage in the knee&nbsp;joint.&nbsp;<\/p>\n","protected":false},"author":2,"featured_media":16386,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wp_typography_post_enhancements_disabled":false,"footnotes":""},"categories":[262],"tags":[],"class_list":["post-16972","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-2025-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/16972","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/comments?post=16972"}],"version-history":[{"count":3,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/16972\/revisions"}],"predecessor-version":[{"id":16975,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/posts\/16972\/revisions\/16975"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media\/16386"}],"wp:attachment":[{"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/media?parent=16972"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/categories?post=16972"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bm-t.de\/en\/wp-json\/wp\/v2\/tags?post=16972"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}