{"id":10498,"date":"2024-02-29T01:19:00","date_gmt":"2024-02-28T19:49:00","guid":{"rendered":"https:\/\/www.rootsanalysis.com\/blog\/?p=10498"},"modified":"2024-05-09T12:52:32","modified_gmt":"2024-05-09T07:22:32","slug":"cell-therapy-pipeline-update-talaris-therapeutics-announces-initiation-of-phase-3-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.rootsanalysis.com\/blog\/cell-therapy-pipeline-update-talaris-therapeutics-announces-initiation-of-phase-3-clinical-trial\/","title":{"rendered":"Cell Therapy Pipeline Update: Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"380\" height=\"284\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Cell-Therapy-Talaris-Therapeutics-Logo-Roots.webp\" alt=\"Image for Talaris Therapeutics logo \" class=\"wp-image-17656\" style=\"object-fit:contain;width:300px;height:227px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Cell-Therapy-Talaris-Therapeutics-Logo-Roots.webp 380w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Cell-Therapy-Talaris-Therapeutics-Logo-Roots-300x224.webp 300w\" sizes=\"auto, (max-width: 380px) 100vw, 380px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Cell Therapy pipeline update, Talaris Therapeutics,\u00a0a late-clinical stage biotechnology company based in <a href=\"https:\/\/www.linkedin.com\/company\/talaris-therapeutics\/about\/\">Boston, MA and Louisville, KY<\/a>, announced\u00a0the initiation of FREEDOM-1 (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03995901\">NCT03995901<\/a>), the company\u2019s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What is the objective of the trial:<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This pivotal trial will evaluate the safety and efficacy of a single dose of FCR001, the company\u2019s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What is FCR001:<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose in kidney transplant recipients who received a non-myeloablative conditioning regimen. FCR001 contains the donor&#8217;s CD34+ cells, facilitating cells, and \u03b1\u03b2 T cells. This therapy induces or restores patients&#8217; immune tolerance by establishing stable donor chimerism in the transplant recipient without the need for life-long immunosuppression.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>With the growing stem cell therapy pipeline, do we have enough manufacturing capacity:&nbsp;<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Given complex manufacturing protocols, and high development costs, stem cell therapy developers are increasingly becoming dependent on contract service providers to leverage long term expertise and optimize operating expenses.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"166\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Need-for-Contract-Manufacturing-Cell-Therapy-Roots-1024x166.webp\" alt=\"Infographic: why there is a need for Outsourcing in stem cell therapies as per Roots Analysis\" class=\"wp-image-17658\" style=\"object-fit:contain;width:800px;height:132px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Need-for-Contract-Manufacturing-Cell-Therapy-Roots-1024x166.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Need-for-Contract-Manufacturing-Cell-Therapy-Roots-300x49.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Need-for-Contract-Manufacturing-Cell-Therapy-Roots-768x125.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Need-for-Contract-Manufacturing-Cell-Therapy-Roots-1536x250.webp 1536w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Need-for-Contract-Manufacturing-Cell-Therapy-Roots.webp 1908w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><strong>Who are the CMOs that can manufacture stem cell therapies:&nbsp;<\/strong>More than 80 industry \/ non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing for various types of stem cell therapies.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"160\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Current-CMO-Landscape-Upcoming-Trends-Stem-Cell-Therapy-Roots-1024x160.webp\" alt=\"Infographic: Stem Cell Contract Manufacturers future evolution of the market as Roots Analysis\" class=\"wp-image-17659\" style=\"object-fit:contain;width:800px;height:126px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Current-CMO-Landscape-Upcoming-Trends-Stem-Cell-Therapy-Roots-1024x160.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Current-CMO-Landscape-Upcoming-Trends-Stem-Cell-Therapy-Roots-300x47.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Current-CMO-Landscape-Upcoming-Trends-Stem-Cell-Therapy-Roots-768x120.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Current-CMO-Landscape-Upcoming-Trends-Stem-Cell-Therapy-Roots-1536x241.webp 1536w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Current-CMO-Landscape-Upcoming-Trends-Stem-Cell-Therapy-Roots.webp 1908w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">With increasing application in regenerative medicine and other neuro-related disorders, stem cell therapies have gained traction in the last few years. In fact, more than 500 interventional stem cell-related clinical studies have been registered in the last five years.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"474\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Clinical-Studies-in-Stem-Cell-Therapy-Roots-1024x474.webp\" alt=\"Infographic: Stem Cell Therapy - Demand vs Supply representation \" class=\"wp-image-17660\" style=\"object-fit:contain;width:800px;height:372px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Clinical-Studies-in-Stem-Cell-Therapy-Roots-1024x474.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Clinical-Studies-in-Stem-Cell-Therapy-Roots-300x139.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Clinical-Studies-in-Stem-Cell-Therapy-Roots-768x356.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Clinical-Studies-in-Stem-Cell-Therapy-Roots-1536x711.webp 1536w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Clinical-Studies-in-Stem-Cell-Therapy-Roots.webp 1930w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Given that stem cell therapy&nbsp;manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies. As a result, stem cell therapy developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs). Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical and commercial-scale manufacturing processes to contract service providers.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The <a href=\"https:\/\/www.rootsanalysis.com\/reports\/stem-cell-therapy-contract-manufacturing-market-2019-2030\/271.html\">stem cell manufacturing market<\/a> for CMO is expected to grow at compounded annual growth rate (CAGR) of 18% during the forecast period 2019 \u2013 2030.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cell Therapy pipeline update, Talaris Therapeutics,\u00a0a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY, announced\u00a0the initiation of FREEDOM-1 (NCT03995901), the company\u2019s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. What is the objective of the trial: This pivotal trial will evaluate the safety and efficacy of a [&hellip;]<\/p>\n","protected":false},"author":21,"featured_media":17268,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[118],"tags":[153,324],"class_list":["post-10498","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cell-therapy","tag-cell-therapy","tag-talaris-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cell Therapy Pipeline: Talaris Therapeutics into Phase 3 Trial<\/title>\n<meta name=\"description\" content=\"Cell therapy pipeline update talaris therapeutics provides update on freedom-1 phase 3 clinical trial of FCR001 in living donor\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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