{"id":7229,"date":"2024-12-05T15:41:24","date_gmt":"2024-12-05T07:41:24","guid":{"rendered":"https:\/\/stemcytebio.com\/?p=7229"},"modified":"2024-12-06T16:03:48","modified_gmt":"2024-12-06T08:03:48","slug":"u-s-fda-approves-stemcyte-biologics-license-application-for-regenecyte-cord-blood-cell-therapy-product","status":"publish","type":"post","link":"https:\/\/stemcytebio.com\/en\/news\/media-coverage\/u-s-fda-approves-stemcyte-biologics-license-application-for-regenecyte-cord-blood-cell-therapy-product\/","title":{"rendered":"U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE\u2122 Cord Blood Cell Therapy Product"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7229\" class=\"elementor elementor-7229\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-531ee23e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"531ee23e\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1aef3018\" data-id=\"1aef3018\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f06ee11 elementor-widget elementor-widget-spacer\" data-id=\"f06ee11\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3be27903 elementor-widget elementor-widget-text-editor\" data-id=\"3be27903\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its HPC, Cord Blood product REGENECYTE<b>\u2122<\/b>, a vital cord blood stem cell therapy for transplantation in patients with blood and immune system disorders. With this approval, StemCyte became the 15th company to receive BLA approval in 2024 and the first commercial U.S. based biotech company to secure a biologics license for cord blood stem cell therapy.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67d5f859 elementor-widget elementor-widget-text-editor\" data-id=\"67d5f859\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>REGENECYTE<b>\u2122<\/b>\u00a0is an allogeneic hematopoietic stem cell therapy derived from human umbilical cord blood. It is approved for unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7479af08 elementor-widget elementor-widget-text-editor\" data-id=\"7479af08\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In addition to REGENECYTE<b>\u2122<\/b>, StemCyte is exploring the potential of its other HPC, Cord Blood products for emerging therapeutic applications, including chronic fatigue syndrome, aging-related diseases, and other conditions associated with suboptimal health. The company is also advancing Phase II clinical trials investigating the use of HPC, Cord Blood in treating long COVID syndrome and acute stroke, reinforcing its commitment to expanding the frontiers of regenerative medicine.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eb70665 elementor-widget elementor-widget-text-editor\" data-id=\"eb70665\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>&#8220;With one of the largest inventories of cord blood stem cells worldwide, StemCyte is uniquely positioned to supply, manufacture, and develop advanced cell therapy products,&#8221; said Dr. Tong\u00a0<span class=\"xn-person\">Young Lee<\/span>, CEO of StemCyte. &#8220;Looking ahead, we are committed to driving the development of innovative therapies, achieving sustainable growth through diversified business strategies, and solidifying our position as a global leader in the field of cell therapy.&#8221;<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45e1c336 elementor-widget elementor-widget-text-editor\" data-id=\"45e1c336\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>StemCyte International Ltd. is expected to be listed on the Taipei Stock Exchange in\u00a0<span class=\"xn-chron\">December 2024<\/span>, marking a significant milestone in its mission to advance regenerative medicine and deliver innovative therapies worldwide.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37c666c elementor-widget elementor-widget-text-editor\" data-id=\"37c666c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><b>About StemCyte:<br class=\"dnr\" \/><\/b>StemCyte Inc., a 100%-owned subsidiary of StemCyte International Ltd., is a cell therapy company with a cGMP-certified facility in\u00a0<span class=\"xn-location\">California, USA<\/span>. StemCyte&#8217;s public cord blood stem cell inventory meets the highest international standards, including those of the FDA, EMA, TFDA, AABB, and FACT. This commitment to quality establishes StemCyte as a key supplier in the field of cell therapy and supports the rapid development of allogeneic cell therapy worldwide.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9451373 elementor-widget elementor-widget-text-editor\" data-id=\"9451373\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>News Source:\u00a0<a href=\"https:\/\/www.prnewswire.com\/news-releases\/us-fda-approves-stemcyte-biologics-license-application-for-regenecyte-cord-blood-cell-therapy-product-302313955.html\" target=\"_blank\" rel=\"noopener\">PR Newswire<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3773df31 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3773df31\" data-element_type=\"widget\" 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