{"id":11085,"date":"2026-09-09T16:54:21","date_gmt":"2026-09-09T08:54:21","guid":{"rendered":"https:\/\/stemcytebio.com\/fda-approved-cord-blood-product\/"},"modified":"2026-09-15T16:54:50","modified_gmt":"2026-09-15T08:54:50","slug":"fda-approved-cord-blood-product","status":"publish","type":"page","link":"https:\/\/stemcytebio.com\/en\/fda-approved-cord-blood-product\/","title":{"rendered":"FDA-Approved Cord Blood Product"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"11085\" class=\"elementor elementor-11085 elementor-10974\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f6d9956 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"f6d9956\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-94c379a\" data-id=\"94c379a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e0623f1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e0623f1\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-32854d6 elementor-invisible\" data-id=\"32854d6\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;}\">\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-079ba32 elementor-widget elementor-widget-heading\" data-id=\"079ba32\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">FDA-Approved Cord Blood Product<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-325c287\" data-id=\"325c287\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b4437dd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b4437dd\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-db53ae4\" data-id=\"db53ae4\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-e570df2 fixtop elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"e570df2\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-8162041\" data-id=\"8162041\" 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-f93ea53 elementor-widget__width-auto uael-nav-menu__breakpoint-mobile uael-nav-menu-toggle-label-yes uael-nav-menu-label-align-left uael-nav-menu__align-left uael-submenu-icon-arrow uael-link-redirect-child elementor-widget elementor-widget-uael-nav-menu\" data-id=\"f93ea53\" data-element_type=\"widget\" data-widget_type=\"uael-nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"uael-nav-menu uael-layout-vertical uael-nav-menu-layout\" data-layout=\"vertical\">\n\t\t\t\t<div role=\"button\" class=\"uael-nav-menu__toggle elementor-clickable\">\n\t\t\t\t\t<span class=\"screen-reader-text\">Main Menu<\/span>\n\t\t\t\t\t<div class=\"uael-nav-menu-icon\">\n\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-caret-down\"><\/i>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-nav-menu-label\">Menu<\/span>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<nav class=\"uael-nav-menu__layout-vertical uael-nav-menu__submenu-arrow\" data-toggle-icon=\"&lt;i aria-hidden=&quot;true&quot; class=&quot;fas fa-caret-down&quot;&gt;&lt;\/i&gt;\" data-close-icon=\"&lt;i aria-hidden=&quot;true&quot; class=&quot;fas fa-caret-up&quot;&gt;&lt;\/i&gt;\" data-full-width=\"yes\"><ul id=\"menu-1-f93ea53\" class=\"uael-nav-menu\"><li id=\"menu-item-11108\" class=\"menu-item menu-item-type-post_type menu-item-object-page parent uael-creative-menu\"><a href=\"https:\/\/stemcytebio.com\/en\/fda-approved-cord-blood-product\/\" class = \"uael-menu-item\">FDA-Approved Cord Blood Product<\/a><\/li>\n<li id=\"menu-item-10584\" class=\"menu-item menu-item-type-post_type menu-item-object-page parent uael-creative-menu\"><a href=\"https:\/\/stemcytebio.com\/en\/certification\/\" class = \"uael-menu-item\">International Certification and Quality Systems<\/a><\/li>\n<li id=\"menu-item-11132\" class=\"menu-item menu-item-type-post_type menu-item-object-page parent uael-creative-menu\"><a href=\"https:\/\/stemcytebio.com\/en\/public-cord-blood-bank\/\" class = \"uael-menu-item\">Public Cord Blood Bank<\/a><\/li>\n<\/ul><\/nav>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-0726c0b elementor-invisible\" data-id=\"0726c0b\" data-element_type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\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-ef9bdce elementor-widget elementor-widget-text-editor\" data-id=\"ef9bdce\" 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 class=\"PDq2pG_selectionAnchorContainer\" data-start=\"34\" data-end=\"231\">REGENECYTE\u00ae (HPC, Cord Blood), a cord blood product developed by StemCyte, received U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) in November 2024.<\/p><p data-start=\"233\" data-end=\"392\">REGENECYTE\u00ae is licensed under BLA No. 125764 and U.S. License No. 2280 and is currently listed among the FDA\u2019s Approved Cellular and Gene Therapy Products.<\/p><p data-start=\"394\" data-end=\"765\">This approval demonstrates that StemCyte has established manufacturing, quality control, and regulatory systems for REGENECYTE\u00ae that meet U.S. requirements for licensed biological products. It also reflects StemCyte\u2019s capabilities in advancing cord blood resources beyond long-term banking and clinical supply toward the development of standardized cellular products.<\/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-8ee7ee7 elementor-widget elementor-widget-text-editor\" data-id=\"8ee7ee7\" 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 class=\"PDq2pG_selectionAnchorContainer\" data-start=\"46\" data-end=\"167\">REGENECYTE\u00ae is an FDA-approved cord blood-derived hematopoietic progenitor cell product developed by StemCyte. It is indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment, for the purpose of hematopoietic and immunologic reconstitution.<\/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-2c30131 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2c30131\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\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-3a6c5e7 elementor-widget elementor-widget-heading\" data-id=\"3a6c5e7\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">REGENECYTE\u00ae Receives U.S. FDA Biologics License Approval<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3929e43 elementor-widget elementor-widget-text-editor\" data-id=\"3929e43\" 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 class=\"PDq2pG_selectionAnchorContainer\" data-start=\"31\" data-end=\"227\">In November 2024, the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for REGENECYTE\u00ae, StemCyte\u2019s cord blood product, and issued U.S. License No. 2280.<\/p><p data-start=\"229\" data-end=\"461\">According to the FDA approval information, the Proper Name of REGENECYTE\u00ae is HPC, Cord Blood. StemCyte, Inc. is the applicant and manufacturer, and the licensed manufacturing facility is located in Baldwin Park, California, USA.<\/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-ac37f56 uael-header-sticky-no uael-border-yes elementor-widget elementor-widget-uael-table\" data-id=\"ac37f56\" data-element_type=\"widget\" data-widget_type=\"uael-table.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div itemscope class=\"uael-table-wrapper\" itemtype=\"http:\/\/schema.org\/Table\">\n\t\t<table id=\"uael-table-id-ac37f56\" class=\"uael-text-break uael-column-rules uael-table\" data-sort-table=\"no\" data-show-entry=\"no\" data-searchable=\"no\" data-responsive=\"no\">\n\t\t\t\t<tbody>\n\t\t\t<!-- ROWS -->\n\t\t\t\t\t\t\t\t\t\t<tr data-entry=\"1\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-a3049cb\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Product Name<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-feeaefe\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">REGENECYTE\u00ae<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"2\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-ef055bb\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">FDA Proper Name<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-9b95eca\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">HPC, Cord Blood<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"3\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-c64d96d\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Applicant and Manufacturer<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-28e7505\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">StemCyte, Inc.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"4\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-812db58\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">BLA \/ STN<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-9780a55\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">125764<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"5\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-9d43f53\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">U.S. License No.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-bbdda2b\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">2280<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"6\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-b9594b1\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Approval Date<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-a4083fe\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">November 20, 2024<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"7\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-a317da7\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Approval Type<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-1347fca\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\"> Biologics License Application, BLA<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"8\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-c752ac0\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Licensed Manufacturing Facility<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-8d1bd99\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Baldwin Park, California, USA <\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"9\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-8074da7\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Approved Indication<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-3b2b7cc\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Hematopoietic and Immunologic Reconstitution in Unrelated Donor Hematopoietic Progenitor Cell Transplantation<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t<\/tbody>\n\t<\/table>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b14c483 elementor-widget elementor-widget-text-editor\" data-id=\"b14c483\" 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 class=\"PDq2pG_selectionAnchorContainer\" data-start=\"1425\" data-end=\"1553\">REGENECYTE\u00ae is currently listed among the U.S. FDA\u2019s Approved Cellular and Gene Therapy Products.<\/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-9dd3fd8 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"9dd3fd8\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\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-936f621 elementor-widget elementor-widget-heading\" data-id=\"936f621\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FDA-Approved Indication for REGENECYTE\u00ae<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7cc46e9 elementor-widget elementor-widget-text-editor\" data-id=\"7cc46e9\" 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<div class=\"qMYqUG_convSearchResultHighlightRoot\"><div class=\"\" data-turn-id-container=\"request-6851211a-cf08-8010-bc75-00410328a29c-35\" data-is-intersecting=\"true\"><section class=\"text-token-text-primary w-full focus:outline-none has-data-writing-block:pointer-events-none [&amp;:has([data-writing-block])&gt;*]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]\" dir=\"auto\" data-turn-id=\"request-6851211a-cf08-8010-bc75-00410328a29c-35\" data-turn-id-container=\"request-6851211a-cf08-8010-bc75-00410328a29c-35\" data-testid=\"conversation-turn-92\" data-turn=\"assistant\"><div class=\"text-base my-auto mx-auto pb-8 [--thread-content-margin:var(--thread-content-margin-xs,calc(var(--spacing)*4))] @w-sm\/main:[--thread-content-margin:var(--thread-content-margin-sm,calc(var(--spacing)*6))] @w-lg\/main:[--thread-content-margin:var(--thread-content-margin-lg,calc(var(--spacing)*16))] px-(--thread-content-margin)\"><div class=\"[--thread-content-max-width:40rem] @w-lg\/main:[--thread-content-max-width:48rem] mx-auto max-w-(--thread-content-max-width) flex-1 group\/turn-messages focus-visible:outline-hidden relative flex w-full min-w-0 flex-col agent-turn\" data-conversation-screenshot-content=\"\"><div class=\"flex max-w-full flex-col gap-4 grow\"><div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal outline-none keyboard-focused:focus-ring [.text-message+&amp;]:mt-1\" dir=\"auto\" tabindex=\"0\" data-message-author-role=\"assistant\" data-message-id=\"b8dcf04c-5938-4f47-920f-b5edb23c11f0\" data-message-model-slug=\"gpt-5-6\" data-turn-start-message=\"true\"><div class=\"flex w-full flex-col gap-1 empty:hidden\"><div class=\"markdown prose dark:prose-invert wrap-break-word w-full light markdown-new-styling\"><p class=\"PDq2pG_selectionAnchorContainer\" data-start=\"9\" data-end=\"397\">According to the U.S. FDA-approved indication, REGENECYTE\u00ae may be used in 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><p data-start=\"399\" data-end=\"806\">Cord blood hematopoietic stem cell transplantation is currently used clinically to treat nearly 80 diseases, including cancers, blood disorders, immune system disorders, and metabolic disorders. Whether cord blood transplantation is appropriate for an individual patient depends on the type of disease, the patient\u2019s condition, cell matching results, and the professional assessment of the medical team.<\/p><p data-start=\"808\" data-end=\"1054\" data-is-last-node=\"\" data-is-only-node=\"\">REGENECYTE\u00ae should be evaluated and administered by a medical team experienced in hematopoietic stem cell transplantation, based on the patient\u2019s condition, the product\u2019s FDA-approved labeling, and applicable medical standards and guidelines.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><\/div>\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-0b0f1b9 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"0b0f1b9\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\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-fef9289 elementor-widget elementor-widget-heading\" data-id=\"fef9289\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">From Cord Blood Banking to Standardized Cellular Products<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-511f4ed elementor-widget elementor-widget-text-editor\" data-id=\"511f4ed\" 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 dir=\"ltr\">Obtaining FDA BLA approval represents more than the approval of a regulatory application. It reflects a comprehensive body of data covering product specifications, manufacturing processes, quality control, testing methods, process validation, product release and stability, as well as the safety and efficacy data supporting the application.<\/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-e24c9d6 elementor-widget elementor-widget-text-editor\" data-id=\"e24c9d6\" 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<div class=\"\" data-turn-id-container=\"a251b1c4-397b-4f87-b52f-aed1e94f6295\" data-is-intersecting=\"true\"><strong style=\"font-size: 16px;\" data-start=\"0\" data-end=\"50\" data-is-last-node=\"\" data-is-only-node=\"\">REGENECYTE\u00ae product management process covers:<\/strong><\/div>\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-f7e53c6 elementor-widget elementor-widget-text-editor\" data-id=\"f7e53c6\" 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>Donor and Cell Source Management \u2192 Cord Blood Processing and Storage \u2192 Quality Testing \u2192 Process Validation and Product Release \u2192 Regulatory Review \u2192 Clinical Supply<\/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-3a80975 elementor-widget elementor-widget-text-editor\" data-id=\"3a80975\" 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<div class=\"qMYqUG_convSearchResultHighlightRoot\"><div class=\"\" data-turn-id-container=\"request-6851211a-cf08-8010-bc75-00410328a29c-40\" data-is-intersecting=\"true\"><section class=\"text-token-text-primary w-full focus:outline-none has-data-writing-block:pointer-events-none [&amp;:has([data-writing-block])&gt;*]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]\" dir=\"auto\" data-turn-id=\"request-6851211a-cf08-8010-bc75-00410328a29c-40\" data-turn-id-container=\"request-6851211a-cf08-8010-bc75-00410328a29c-40\" data-testid=\"conversation-turn-102\" data-turn=\"assistant\"><div class=\"text-base my-auto mx-auto pb-8 [--thread-content-margin:var(--thread-content-margin-xs,calc(var(--spacing)*4))] @w-sm\/main:[--thread-content-margin:var(--thread-content-margin-sm,calc(var(--spacing)*6))] @w-lg\/main:[--thread-content-margin:var(--thread-content-margin-lg,calc(var(--spacing)*16))] px-(--thread-content-margin)\"><div class=\"[--thread-content-max-width:40rem] @w-lg\/main:[--thread-content-max-width:48rem] mx-auto max-w-(--thread-content-max-width) flex-1 group\/turn-messages focus-visible:outline-hidden relative flex w-full min-w-0 flex-col agent-turn\" data-conversation-screenshot-content=\"\"><div class=\"flex max-w-full flex-col gap-4 grow\"><div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal outline-none keyboard-focused:focus-ring [.text-message+&amp;]:mt-1\" dir=\"auto\" tabindex=\"0\" data-message-author-role=\"assistant\" data-message-id=\"8014e329-f58d-4dfb-93ab-e0f2bf95e16b\" data-message-model-slug=\"gpt-5-6\" data-turn-start-message=\"true\"><div class=\"flex w-full flex-col gap-1 empty:hidden\"><div class=\"markdown prose dark:prose-invert wrap-break-word w-full light markdown-new-styling\"><p class=\"PDq2pG_selectionAnchorContainer\" data-start=\"8\" data-end=\"460\" data-is-last-node=\"\" data-is-only-node=\"\">StemCyte has capabilities extending beyond cord blood banking and global clinical supply. The company has also established practical expertise in manufacturing, quality management, and regulatory submissions for cord blood products in accordance with approved specifications. These capabilities provide an important foundation for StemCyte\u2019s continued advancement of cellular product development, clinical research, and international collaboration.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><\/div>\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-08ebe80 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"08ebe80\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\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-3be0620 elementor-widget elementor-widget-heading\" data-id=\"3be0620\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Frequently Asked Questions (FAQ)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-73239a0 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"73239a0\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-e9de7b6\" data-id=\"e9de7b6\" 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-7413984 elementor-widget elementor-widget-accordion\" data-id=\"7413984\" data-element_type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1211\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1211\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Has StemCyte Received U.S. FDA Approval\uff1f<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1211\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1211\"><div class=\"qMYqUG_convSearchResultHighlightRoot\"><div class=\"\" data-turn-id-container=\"request-6851211a-cf08-8010-bc75-00410328a29c-43\" data-is-intersecting=\"true\"><section class=\"text-token-text-primary w-full focus:outline-none has-data-writing-block:pointer-events-none [&amp;:has([data-writing-block])&gt;*]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]\" dir=\"auto\" data-turn-id=\"request-6851211a-cf08-8010-bc75-00410328a29c-43\" data-turn-id-container=\"request-6851211a-cf08-8010-bc75-00410328a29c-43\" data-testid=\"conversation-turn-108\" data-turn=\"assistant\"><div class=\"text-base my-auto mx-auto pb-8 [--thread-content-margin:var(--thread-content-margin-xs,calc(var(--spacing)*4))] @w-sm\/main:[--thread-content-margin:var(--thread-content-margin-sm,calc(var(--spacing)*6))] @w-lg\/main:[--thread-content-margin:var(--thread-content-margin-lg,calc(var(--spacing)*16))] px-(--thread-content-margin)\"><div class=\"[--thread-content-max-width:40rem] @w-lg\/main:[--thread-content-max-width:48rem] mx-auto max-w-(--thread-content-max-width) flex-1 group\/turn-messages focus-visible:outline-hidden relative flex w-full min-w-0 flex-col agent-turn\" data-conversation-screenshot-content=\"\"><div class=\"flex max-w-full flex-col gap-4 grow\"><div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal outline-none keyboard-focused:focus-ring [.text-message+&amp;]:mt-1\" dir=\"auto\" tabindex=\"0\" data-message-author-role=\"assistant\" data-message-id=\"44204436-ede4-4244-8f16-dde38b9dfbe3\" data-message-model-slug=\"gpt-5-6\" data-turn-start-message=\"true\"><div class=\"flex w-full flex-col gap-1 empty:hidden\"><div class=\"markdown prose dark:prose-invert wrap-break-word w-full light markdown-new-styling\"><p class=\"PDq2pG_selectionAnchorContainer\" data-start=\"0\" data-end=\"167\" data-is-last-node=\"\" data-is-only-node=\"\">Yes. REGENECYTE\u00ae (HPC, Cord Blood), StemCyte\u2019s cord blood product, received U.S. FDA BLA approval in 2024. Its BLA\/STN is 125764, and its U.S. License No. is 2280.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1212\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1212\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is REGENECYTE\u00ae\uff1f<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1212\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1212\"><p>REGENECYTE\u00ae is a human cord blood-derived hematopoietic progenitor cell product developed by StemCyte. Its FDA Proper Name is HPC, Cord Blood, and it is an allogeneic cellular biologic product.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1213\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1213\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is REGENECYTE\u00ae approved by the FDA for\uff1f<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1213\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1213\"><p>The FDA has approved REGENECYTE\u00ae for use in unrelated donor hematopoietic progenitor cell transplantation procedures, in conjunction with an appropriate preparative regimen, for hematopoietic and immunologic reconstitution.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1214\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1214\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is a BLA?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1214\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1214\"><p>BLA stands for Biologics License Application, the application submitted to the U.S. FDA for authorization to market a biological product. Once a BLA is approved, the applicant may legally distribute the biological product in the United States in accordance with the FDA-approved product, manufacturing facility, indication, and labeling.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p> [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"content-type":"","site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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