{"id":9362,"date":"2026-01-26T13:36:08","date_gmt":"2026-01-26T05:36:08","guid":{"rendered":"https:\/\/stemcytebio.com\/?p=9362"},"modified":"2026-01-27T17:06:07","modified_gmt":"2026-01-27T09:06:07","slug":"stemcyte-announces-fda-clearance-of-expanded-access-program-for-regenecyte-hpc-cord-blood-to-address-unmet-need-in-long-covid","status":"publish","type":"post","link":"https:\/\/stemcytebio.com\/en\/news\/media-coverage\/stemcyte-announces-fda-clearance-of-expanded-access-program-for-regenecyte-hpc-cord-blood-to-address-unmet-need-in-long-covid\/","title":{"rendered":"StemCyte Announces FDA Clearance of Expanded Access Program for RegeneCyte\u00ae (HPC, Cord Blood) to Address Unmet Need in Long COVID"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9362\" class=\"elementor elementor-9362\">\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><span class=\"legendSpanClass\">BALDWIN PARK, Calif.<\/span>,\u00a0<span class=\"legendSpanClass\">Jan. 26, 2026<\/span>\u00a0\/PRNewswire\/ &#8212;\u00a0StemCyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared an Expanded Access (EA) program for\u00a0<b>RegeneCyte<sup>\u00ae<\/sup><\/b>, the company&#8217;s FDA-licensed hematopoietic progenitor cell (HPC) therapy. This milestone enables eligible patients suffering from the debilitating effects of\u00a0<b>Post-Acute Sequelae of SARS-CoV-2 (Long COVID)<\/b>\u00a0to access the therapy while StemCyte continues its pivotal clinical research.<\/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>This EA program follows compelling data from StemCyte&#8217;s Phase IIa clinical trials. In those studies,\u00a0<b>85% of Long COVID patients<\/b>\u00a0treated with RegeneCyte<sup>\u00ae<\/sup>\u00a0experienced a statistically significant resolution of chronic fatigue, compared to just 20% in the placebo group. By authorizing Expanded Access, the FDA is providing a vital pathway for patients who are severely impacted by the syndrome but may not meet the specific enrollment criteria for ongoing Phase III multi-center trials.<\/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>&#8220;The FDA&#8217;s clearance of this program is a significant validation of the safety and therapeutic potential of RegeneCyte<sup>\u00ae<\/sup>, our HPC-cord blood product,&#8221; said Dr. Tong-Young Lee, CEO of StemCyte. &#8220;With our RMAT (Regenerative Medicine Advanced Therapy) designation already in place, this program allows us to bridge the gap for patients in need as we continue advancing RegeneCyte<sup>\u00ae\u00a0<\/sup>through the clinical development and regulatory pathway.&#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-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>The clearance of this program underscores the vital importance of\u00a0<b>newborn stem cell preservation<\/b>. As regenerative medicine continues to evolve, RegeneCyte<sup>\u00ae<\/sup>\u00a0serves as a primary example of how stored cord blood is being transformed into life-saving therapies for conditions previously thought untreatable, like Long COVID.<\/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>RegeneCyte<sup>\u00ae<\/sup>\u00a0is currently the only FDA-licensed cord blood product being evaluated in U.S. clinical trials for Long COVID. This EA program further solidifies StemCyte&#8217;s transition from a premier cord blood bank to a leader in regenerative 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-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>Physician Inquiry and Patient Eligibility<\/b>\u00a0The Expanded Access program is intended for patients with serious or life-threatening Long COVID symptoms who have exhausted standard treatment options. StemCyte will work directly with treating physicians to facilitate access under the FDA&#8217;s compassionate use framework.<\/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-f0f6ced elementor-widget elementor-widget-text-editor\" data-id=\"f0f6ced\" 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\u00a0StemCyte<\/b>\u00a0StemCyte is a global regenerative medicine company dedicated to developing innovative cell therapies. With a foundation in FDA-licensed cord blood products and an extensive global cell bank, StemCyte is advancing a robust pipeline targeting Long COVID, stroke, and spinal cord injury.<\/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-d371cb8 elementor-widget elementor-widget-text-editor\" data-id=\"d371cb8\" 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>Forward-Looking Statements<\/b>\u00a0This release contains forward-looking statements regarding the efficacy of RegeneCyte<sup>\u00ae<\/sup>\u00a0and the implementation of the Expanded Access program. Actual results may differ based on clinical outcomes and regulatory requirements.<\/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-7672def elementor-widget elementor-widget-text-editor\" data-id=\"7672def\" 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>Media Contact<\/b><br class=\"dnr\" \/>Michael S. Teufenkjian<br class=\"dnr\" \/>Marketing Manager<br class=\"dnr\" \/><a href=\"mailto:mteufenkjian@stemcyte.com\" target=\"_blank\" rel=\"nofollow noopener\">mteufenkjian@stemcyte.com<\/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-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\/stemcyte-announces-fda-clearance-of-expanded-access-program-for-regenecyte-hpc-cord-blood-to-address-unmet-need-in-long-covid-302669830.html?tc=eml_cleartime\" 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\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/stemcytebio.com\/en\/news\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-long-arrow-alt-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Back<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p> [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":1801,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","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":"set","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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[73,88],"tags":[],"class_list":["post-9362","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-media-coverage","category-news"],"_links":{"self":[{"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/posts\/9362","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/comments?post=9362"}],"version-history":[{"count":10,"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/posts\/9362\/revisions"}],"predecessor-version":[{"id":9385,"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/posts\/9362\/revisions\/9385"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/media\/1801"}],"wp:attachment":[{"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/media?parent=9362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/categories?post=9362"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stemcytebio.com\/en\/wp-json\/wp\/v2\/tags?post=9362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}