{"id":24518,"date":"2023-09-12T04:48:00","date_gmt":"2023-09-11T20:48:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=24518"},"modified":"2023-09-12T05:39:42","modified_gmt":"2023-09-11T21:39:42","slug":"blue-journal%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e9%97%b4%e5%85%85%e8%b4%a8%e5%b9%b2%e7%bb%86%e8%83%9e%e4%bf%ae%e5%a4%8d%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e6%84%9f%e6%9f%93%e7%9b%b8","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=24518","title":{"rendered":"[Blue Journal\u53d1\u8868\u8bba\u6587]\uff1a\u95f4\u5145\u8d28\u5e72\u7ec6\u80de\u4fee\u590d\u65b0\u51a0\u75c5\u6bd2\u611f\u67d3\u76f8\u5173ARDS"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">Repair of Acute Respiratory Distress Syndrome in COVID-19 by Stromal Cells (REALIST-COVID Trial): A Multicenter, Randomized, Controlled Clinical Trial<\/h1>\n\n\n\n<h3 class=\"wp-block-heading\">Ellen A. Gorman,\u00a0\u00a0<a href=\"https:\/\/orcid.org\/0000-0002-8945-8434\"><\/a>Jennifer Rynne,\u00a0\u00a0Hannah J. Gardiner, et al<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\">Am J Respir Crit Care Med 2023; 208: 256-269<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\">Abstract<\/h4>\n\n\n\n<p><strong>Rationale:<\/strong>&nbsp;Mesenchymal stromal cells (MSCs) may modulate inflammation, promoting repair in coronavirus disease (COVID-19)\u2013related acute respiratory distress syndrome (ARDS).<\/p>\n\n\n\n<p><strong>Objectives:<\/strong>&nbsp;We investigated the safety and efficacy of ORBCEL-C (CD362 [cluster of differentiation 362]\u2013enriched, umbilical cord\u2013derived MSCs) in COVID-19\u2013related ARDS.<\/p>\n\n\n\n<p><strong>Methods:<\/strong>&nbsp;In this multicenter, randomized, double-blind, allocation-concealed, placebo-controlled trial (NCT 03042143), patients with moderate to severe COVID-19\u2013related ARDS were randomized to receive ORBCEL-C (400 million cells) or placebo (Plasma-Lyte 148). The primary safety and efficacy outcomes were the incidence of serious adverse events and oxygenation index at Day 7, respectively. Secondary outcomes included respiratory compliance, driving pressure, Pa<sub>O2<\/sub>:Fi<sub>O2<\/sub>&nbsp;ratio, and Sequential Organ Failure Assessment score. Clinical outcomes relating to duration of ventilation, lengths of ICU and hospital stays, and mortality were collected. Long-term follow-up included diagnosis of interstitial lung disease at 1\u2009year and significant medical events and mortality at 2\u2009years. Transcriptomic analysis was performed on whole blood at Days 0, 4, and 7.<\/p>\n\n\n\n<p><strong>Measurements and Main Results:<\/strong>\u00a0Sixty participants were recruited (final analysis:\u00a0<em>n<\/em>\u2009=\u200930 received ORBCEL-C,\u00a0<em>n<\/em>\u2009=\u200929 received placebo; 1 participant in the placebo group withdrew consent). Six serious adverse events occurred in the ORBCEL-C group and three in the placebo group (risk ratio, 2.9 [95% confidence interval, 0.6\u201313.2];\u00a0<em>P<\/em>\u2009=\u20090.25). Day 7 mean (SD) oxygenation index did not differ (ORBCEL-C, 98.3 [57.2] cm H<sub>2<\/sub>O\/kPa; placebo, 96.6 [67.3] cm H<sub>2<\/sub>O\/kPa). There were no differences in secondary surrogate outcomes or in mortality at Day 28, Day 90, 1\u2009year, or 2\u2009years. There was no difference in the prevalence of interstitial lung disease at 1\u2009year or significant medical events up to 2\u2009years. ORBCEL-C modulated the peripheral blood transcriptome.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.atsjournals.org\/na101\/home\/literatum\/publisher\/thoracic\/journals\/content\/ajrccm\/2023\/ajrccm.2023.208.issue-3\/rccm.202302-0297oc\/20230720\/images\/large\/rccm.202302-0297ocf1.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.atsjournals.org\/na101\/home\/literatum\/publisher\/thoracic\/journals\/content\/ajrccm\/2023\/ajrccm.2023.208.issue-3\/rccm.202302-0297oc\/20230720\/images\/large\/rccm.202302-0297ocf2.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.atsjournals.org\/na101\/home\/literatum\/publisher\/thoracic\/journals\/content\/ajrccm\/2023\/ajrccm.2023.208.issue-3\/rccm.202302-0297oc\/20230720\/images\/large\/rccm.202302-0297ocf3.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.atsjournals.org\/na101\/home\/literatum\/publisher\/thoracic\/journals\/content\/ajrccm\/2023\/ajrccm.2023.208.issue-3\/rccm.202302-0297oc\/20230720\/images\/large\/rccm.202302-0297ocf4.jpeg\" alt=\"\"\/><\/figure>\n\n\n\n<p><strong>Conclusion:<\/strong>&nbsp;ORBCEL-C MSCs were safe in subjects with moderate to severe COVID-19\u2013related ARDS but did not improve surrogates of pulmonary organ dysfunction.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Repair of Acute Respiratory Distress Syndrome in COVID- [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24518"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=24518"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24518\/revisions"}],"predecessor-version":[{"id":24661,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24518\/revisions\/24661"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24518"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24518"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24518"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}