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Remestemcel-L Therapy for COVID-19-Associated Multisystem Inflammatory Syndrome in Children.
Eckard, Allison Ross; Borow, Kenneth M; Mack, Elizabeth H; Burke, Elizabeth; Atz, Andrew M.
  • Eckard AR; Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina; eckarda@musc.edu.
  • Borow KM; Borow Consulting Group, Bryn Mawr, Pennsylvania; and.
  • Mack EH; Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.
  • Burke E; Mesoblast, Inc, New York, New York.
  • Atz AM; Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.
Pediatrics ; 147(5)2021 05.
Article in English | MEDLINE | ID: covidwho-1083679
ABSTRACT
Multisystem inflammatory syndrome in children (MIS-C) is a serious postinfectious immune dysregulation associated with coronavirus disease 2019 that may present with severe and life-threatening cardiovascular dysfunction, hemodynamic instability, shock, and multisystem organ failure. Optimal treatment is unknown. Current standard of care consists of nonspecific anti-inflammatory and antithrombotic therapies. Interventions that target MIS-C's distinctive clinical features and immunophenotype are indicated. Remestemcel-L, an investigational mesenchymal stromal cell therapy, is a promising candidate for treatment of MIS-C because of its beneficial anti-inflammatory, immunomodulatory, endothelial function and vascular stabilizing effects, which align well with the pathophysiology of MIS-C. Here, we present the first two patients with life-threatening MIS-C ever treated with remestemcel-L under an expanded access program. Both were previously healthy children without any indication of previous coronavirus disease 2019 infection or exposure. They presented with severe clinical illness including myocardial dysfunction, hemodynamic instability, hypotension, acute kidney injury, and shock. At the time of hospital admission, both had negative polymerase chain reaction (PCR) test results and positive serology results for severe acute respiratory syndrome coronavirus 2. Both children received standard of care MIS-C treatment. Although the patients showed some clinical improvement, left ventricular ejection fraction remained reduced and inflammatory biomarkers remained significantly elevated. When treated with two intravenous doses of remestemcel-L separated by 48 hours, rapid normalization of left ventricular ejection fraction, notable reductions in biomarkers of systemic and cardiac inflammation, and improved clinical status occurred. Neither child experienced adverse effects associated with remestemcel-L administration. This treatment appears promising as a novel immunomodulatory cellular therapy for children with clinically significant cardiovascular manifestations of MIS-C.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Biological Products / Systemic Inflammatory Response Syndrome / COVID-19 Drug Treatment / Anti-Inflammatory Agents Type of study: Case report / Prognostic study Topics: Vaccines Limits: Child / Child, preschool / Female / Humans / Male Language: English Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Biological Products / Systemic Inflammatory Response Syndrome / COVID-19 Drug Treatment / Anti-Inflammatory Agents Type of study: Case report / Prognostic study Topics: Vaccines Limits: Child / Child, preschool / Female / Humans / Male Language: English Year: 2021 Document Type: Article