{"id":7366,"date":"2024-10-03T15:45:00","date_gmt":"2024-10-03T07:45:00","guid":{"rendered":"https:\/\/stemcytebio.com\/?p=7366"},"modified":"2026-01-28T11:59:07","modified_gmt":"2026-01-28T03:59:07","slug":"stemcytes-hpc-cord-blood-receives-rmat-designation-for-long-covid-19-treatment","status":"publish","type":"post","link":"https:\/\/stemcytebio.com\/en\/news\/media-coverage\/stemcytes-hpc-cord-blood-receives-rmat-designation-for-long-covid-19-treatment\/","title":{"rendered":"StemCyte&#8217;s HPC Cord Blood Receives RMAT Designation for Long COVID-19 Treatment"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7366\" class=\"elementor elementor-7366\">\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 announced today that its Hematopoietic Progenitor Cell Cord Blood therapy (HPC Cord Blood) has officially obtained the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of Long COVID-19 syndrome. StemCyte is one of the few\u00a0cell therapy companies\u00a0in\u00a0<span class=\"xn-location\">the United States<\/span>\u00a0to receive the FDA-granted RMAT designation.<\/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>Long COVID-19 syndrome is a severe and persistent consequence of COVID-19, for which no effective treatment currently exists. StemCyte&#8217;s HPC Cord Blood is the world&#8217;s first cord blood cell therapy to receive FDA approval for a Phase II clinical trial specifically for Long COVID-19. The RMAT designation, which was largely based on positive outcomes from the Phase II trial, enables StemCyte to collaborate closely with the FDA to expedite development, gain priority review, and leverage accelerated approval opportunities for future indications.<\/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>The Phase II clinical trial of HPC Cord Blood was successfully completed within eight months in\u00a0<span class=\"xn-location\">the United States<\/span>, achieving full patient enrollment. StemCyte expects to unblind the results soon. The RMAT designation not only brings hope to patients suffering from Long COVID-19 but also expands the potential applications for HPC Cord Blood. Currently, StemCyte is in the planning stages for a Phase III clinical trial under FDA guidance. Significant progress has also been made on the Biologics License Application (BLA) for the HPC Cord Blood product (RegeneCyte), with StemCyte expecting to receive FDA approval by the end of the year to\u00a0utilize umbilical cord blood-derived hematopoietic stem cells as a treatment for cancers, blood disorders, and immune deficiencies.<\/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 FDA&#8217;s RMAT designation is reserved for products that show breakthrough therapeutic potential and address significant unmet medical needs. According to the FDA, as of\u00a0<span class=\"xn-chron\">June 2024<\/span>, there have been 279 RMAT applications submitted worldwide, with successful approvals including Kymriah\u00ae, Abecma\u00ae, and Breyanzi\u00ae CAR-T treatments. StemCyte is honored to be the only cell therapy company to achieve this milestone for its HPC Cord Blood.<\/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 is a leader in the field of regenerative medicine, focusing on the development of innovative therapies utilizing cord blood. With a mission to bring advanced cellular therapies to the market, StemCyte is dedicated to improving health outcomes for patients globally.<\/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\/stemcytes-hpc-cord-blood-receives-rmat-designation-for-long-covid-19-treatment-302266351.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\" data-widget_type=\"button.default\">\n\t\t\t\t<div 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