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[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.20.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.20.4″ _module_preset=”default” custom_margin=”-54px|auto||auto||” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.20.4″ _module_preset=”default” min_height=”272px” custom_margin=”||2px|||” custom_padding=”||0px|||” global_colors_info=”{}”]<\/p>\n
Transforming Hope Into Healing<\/strong><\/span><\/p>\n A groundbreaking\u00a0Phase 1\/2a double-blind, randomized, placebo-controlled trial<\/strong>\u00a0conducted at the\u00a0University of Miami Health System \/ Jackson Memorial Hospital<\/strong>\u00a0has demonstrated the\u00a0safety and remarkable therapeutic potential<\/strong>\u00a0of\u00a0JadiCell umbilical-cord-derived mesenchymal stem cells<\/strong>\u00a0in patients suffering from\u00a0COVID-19\u2013induced Acute Respiratory Distress Syndrome (ARDS)<\/strong>.<\/p>\n Published in\u00a0Stem Cells Translational Medicine (Wiley, 2021)<\/em><\/a> Study Snapshot<\/strong><\/span><\/p>\n Parameter<\/strong><\/p>\n<\/td>\n Details<\/strong><\/p>\n<\/td>\n<\/tr>\n<\/thead>\n\n Study Type<\/strong><\/p>\n<\/td>\n Double-blind, randomized, placebo-controlled<\/p>\n<\/td>\n<\/tr>\n Participants<\/strong><\/p>\n<\/td>\n 24 hospitalized ARDS patients (12 treated, 12 control)<\/p>\n<\/td>\n<\/tr>\n Treatment<\/strong><\/p>\n<\/td>\n Two IV infusions of 100 \u00b1 20 million JadiCells, 72 hours apart<\/p>\n<\/td>\n<\/tr>\n Manufacturing<\/strong><\/p>\n<\/td>\n Conducted under cGMP standards at the Diabetes Research Institute<\/p>\n<\/td>\n<\/tr>\n Cell Origin<\/strong><\/p>\n<\/td>\n Subepithelial lining of umbilical cord (provided by JadiCell, U.S. Patent 9,803,176 B2)<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \n Exceptional Safety Profile<\/strong><\/span><\/p>\n \u201cUC-MSC infusions were safe and showed no treatment-related adverse events.\u201d Clinical Outcomes That Speak Volumes<\/strong><\/span><\/p>\n Outcome<\/strong><\/p>\n<\/td>\n JadiCell Group<\/strong><\/p>\n<\/td>\n Control Group<\/strong><\/p>\n<\/td>\n Statistical Significance<\/strong><\/p>\n<\/td>\n<\/tr>\n<\/thead>\n\n Survival Rate (31 days)<\/strong><\/p>\n<\/td>\n 91%<\/p>\n<\/td>\n 42%<\/p>\n<\/td>\n P = 0.015<\/em><\/p>\n<\/td>\n<\/tr>\n Serious Adverse Events<\/strong><\/p>\n<\/td>\n 2 cases<\/p>\n<\/td>\n 16 cases<\/p>\n<\/td>\n P = 0.008<\/em><\/p>\n<\/td>\n<\/tr>\n Time to Recovery<\/strong><\/p>\n<\/td>\n Significantly shorter<\/p>\n<\/td>\n \u2014<\/p>\n<\/td>\n P = 0.03<\/em><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Survival improved by more than double\u00a0in patients receiving JadiCell therapy.<\/p>\n Stopping the Cytokine Storm<\/strong><\/span><\/p>\n JadiCell treatment caused a\u00a0dramatic decrease in inflammatory cytokines<\/strong>\u00a0driving ARDS severity \u2014 including: \u201cInflammatory cytokine concentrations showed marked and statistically significant decreases from Day 0 to Day 6 only in the JadiCell group.\u201d How JadiCell Works<\/strong><\/span><\/p>\n Suppresses the hyperinflammatory \u201ccytokine storm\u201d responsible for tissue destruction in ARDS.<\/p>\n Promotes regeneration of the alveolar-capillary interface and restoration of oxygen exchange.<\/p>\n Reduces excessive immune activation while supporting protective immune functions.<\/p>\n Patients treated with JadiCells recovered faster, with fewer complications and markedly higher survival.<\/p>\n Why It Matters<\/strong><\/span><\/p>\n This was the\u00a0first randomized, controlled trial<\/strong>\u00a0to demonstrate a\u00a0statistically significant survival benefit<\/strong>\u00a0in ARDS using stem cell therapy. \u201cThese findings strongly support further investigation in larger multicenter trials to establish efficacy.\u201d Summary<\/strong><\/span><\/p>\n \u201cJadiCell therapy in COVID-19 ARDS is safe and associated with significant reductions in mortality, serious adverse events, and recovery time \u2014 accompanied by a profound decline in inflammatory cytokines.\u201d<\/strong> Publication & Acknowledgments<\/strong><\/p>\n <\/span><\/p>\n<\/div>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" JadiCell: A Clinical Breakthrough in Treating ARDSTransforming Hope Into Healing A groundbreaking\u00a0Phase 1\/2a double-blind, randomized, placebo-controlled trial\u00a0conducted at the\u00a0University of Miami Health System \/ Jackson Memorial Hospital\u00a0has demonstrated the\u00a0safety and remarkable therapeutic potential\u00a0of\u00a0JadiCell umbilical-cord-derived mesenchymal stem cells\u00a0in patients suffering from\u00a0COVID-19\u2013induced Acute Respiratory Distress Syndrome (ARDS). Published in\u00a0Stem Cells Translational Medicine (Wiley, 2021)ClinicalTrials.gov Identifier:\u00a0NCT04355728 Study Snapshot […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-132","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/pages\/132","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/comments?post=132"}],"version-history":[{"count":12,"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/pages\/132\/revisions"}],"predecessor-version":[{"id":154,"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/pages\/132\/revisions\/154"}],"wp:attachment":[{"href":"https:\/\/breathebiologics.com\/index.php\/wp-json\/wp\/v2\/media?parent=132"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
ClinicalTrials.gov Identifier:\u00a0NCT04355728<\/a><\/p>\n\n\n
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\u2014\u00a0STEM CELLS Translational Medicine (2021)<\/em><\/p>\n\n\n
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IL-6, TNF-\u03b1, IFN-\u03b3, GM-CSF, PDGF-BB, and RANTES<\/strong>.
These findings confirm JadiCell\u2019s\u00a0immunomodulatory mechanism<\/strong>, helping the body rebalance its immune response and\u00a0heal damaged lung tissue<\/strong>.<\/p>\n
\u2014\u00a0STEM CELLS Translational Medicine (2021)<\/em><\/p>\n\n
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The results open new therapeutic frontiers for:<\/p>\n\n
\u2014\u00a0STEM CELLS Translational Medicine (2021)<\/em><\/p>\n
\u2014\u00a0STEM CELLS Translational Medicine (2021)<\/em><\/p>\n\n