{"id":218551,"date":"2025-07-23T12:02:47","date_gmt":"2025-07-23T17:02:47","guid":{"rendered":"https:\/\/lifeboat.com\/blog\/2025\/07\/cell-therapy-weekly-fda-exemptions-and-breakthrough-therapy-designations"},"modified":"2025-07-23T12:02:47","modified_gmt":"2025-07-23T17:02:47","slug":"cell-therapy-weekly-fda-exemptions-and-breakthrough-therapy-designations","status":"publish","type":"post","link":"https:\/\/lifeboat.com\/blog\/2025\/07\/cell-therapy-weekly-fda-exemptions-and-breakthrough-therapy-designations","title":{"rendered":"Cell therapy weekly: FDA exemptions and Breakthrough Therapy designations"},"content":{"rendered":"<p><a class=\"aligncenter blog-photo\" href=\"https:\/\/lifeboat.com\/blog.images\/cell-therapy-weekly-fda-exemptions-and-breakthrough-therapy-designations.jpg\"><\/a><\/p>\n<p>This week: The US Food and Drug Administration (FDA; MD, USA) has granted a special exemption for an iPSC-derived cell therapy targeting Parkinson\u2019s disease, along with Breakthrough Therapy designations for a CAR-T therapy for a pediatric brain tumor and a gene therapy for Huntington\u2019s disease.<\/p>\n<p>The FDA has granted XellSmart Biopharmaceutical (Suzhou, China) a special exemption to support a clinical trial of XS-411 Injection, the company\u2019s allogeneic, off-the-shelf iPSC-derived dopaminergic neural progenitor cell therapy for Parkinson\u2019s disease. This follows an Investigational New Drug submission in January 2025. In parallel, China\u2019s National Medical Products Administration has approved XS-411 to enter Phase I clinical trials.<\/p>\n<p>Additionally, the FDA has cleared XellSmart\u2019s XS228, an allogeneic, off-the-shelf, clinical-grade iPSC-derived cell therapy for amyotrophic lateral sclerosis (ALS), to begin Phase I trials, marking it as the first-in-class regenerative neural cell therapy for the disease.<\/p>\n<hr>\n<p>The FDA has granted a special exemption for a cell therapy and Breakthrough Therapy designations for a CAR-T therapy and a gene therapy.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This week: The US Food and Drug Administration (FDA; MD, USA) has granted a special exemption for an iPSC-derived cell therapy targeting Parkinson\u2019s disease, along with Breakthrough Therapy designations for a CAR-T therapy for a pediatric brain tumor and a gene therapy for Huntington\u2019s disease. The FDA has granted XellSmart Biopharmaceutical (Suzhou, China) a special [\u2026]<\/p>\n","protected":false},"author":534,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,47],"tags":[],"class_list":["post-218551","post","type-post","status-publish","format-standard","hentry","category-biotech-medical","category-neuroscience"],"_links":{"self":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/218551","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/users\/534"}],"replies":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/comments?post=218551"}],"version-history":[{"count":0,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/218551\/revisions"}],"wp:attachment":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/media?parent=218551"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/categories?post=218551"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/tags?post=218551"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}