Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

Overview

The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.

Full Title of Study: “Intermediate-size Expanded Access of Remestemcel-L, Human Mesenchymal Stromal Cells, for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)”

Study Type

  • Study Type: Expanded Access

Detailed Description

This intermediate-size expanded access protocol plans to treat approximately 50 children or adolescents, male and female, with MIS-C associated with COVID-19. Participants who are 2 months to 17 years of age, inclusive, will be enrolled at multiple clinical sites across the United States.

Interventions

  • Biological: Remestemcel-L
    • Participants may receive up to 2 infusions of 2 x 10^6 remestemcel-L within a 5-day period.
  • Drug: Hydrocortisone
    • Participants who are not currently taking a corticosteroid will receive hydrocortisone, 0.5-1 milligram per kilogram (mg/kg), up to 50 mg IV, at least 30 minutes prior to the infusion of remestemcel-L.
  • Drug: Diphenhydramine
    • Participants will receive diphenhydramine, 0.5-1 mg/kg, up to 50 mg IV, at least 30 minutes prior to the infusion of remestemcel-L.

Participating in This Clinical Trial

Inclusion Criteria 1. 2 months to 17 years of age, inclusive 2. Positive for current or recent SARS-CoV-2 (COVID-19) infection by real-time reverse transcription polymerase chain reaction (RT-PCR), serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms AND no alternative plausible diagnoses 3. Presenting with:

  • Fever (>38.0°C or >100.4°F for ≥24 hours) or reporting subjective fever lasting ≥24 hours – Laboratory evidence of inflammation with high sensitivity C-reactive protein (hsCRP) ≥4.0 milligrams per deciliter (mg/dL) and associated abnormalities of at least one of the following: – elevated erythrocyte sedimentation rate (ESR) – elevated fibrinogen – elevated procalcitonin – elevated d-dimer – elevated ferritin – elevated lactic dehydrogenase (LDH) – elevated interleukin 6 (IL-6) – elevated neutrophils – reduced lymphocytes – low albumin – Clinically severe multisystem illness requiring hospitalization with evidence for cardiac involvement plus at least one other organ involvement (renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological) – Cardiac involvement is defined as reduced left ventricular ejection fraction (<55%) in addition to at least one of the following: – increased troponin I, – increased N-terminal pro-B-type natriuretic peptide (NT-proBNP) or BNP and/or – echocardiographic and/or other imaging evidence of left anterior descending coronary artery (LAD) and/or right coronary artery (RCA) dilation associated with a z-score > 2.5 4. If on mechanical ventilation or ECMO, ≤72 hours post initiation of the respiratory support device Exclusion Criteria 1. Documented other microbial cause for MIS-C including bacterial sepsis, staphylococcal or streptococcal shock syndromes, or infections associated with myocarditis such as enterovirus. Of importance, waiting for results of these investigations should not delay initiation of remestemcel-L therapy. 2. Females who are pregnant or lactating 3. Body mass index (BMI) ≥40 kilograms per square meter (kg/m^2) 4. Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins 5. Aspartate aminotransferase/alanine transaminase (AST/ALT) ≥5x upper limit of normal (ULN) 6. Creatinine clearance <30 mL/min 7. Serum creatinine >2 mg/dL 8. Any end-stage organ disease which in the opinion of the treating physician may possibly affect the safety of the remestemcel-L treatment.
  • Gender Eligibility: All

    Minimum Age: 2 Months

    Maximum Age: 17 Years

    Investigator Details

    • Lead Sponsor
      • Mesoblast International Sàrl
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Kenneth M. Borow, MD, Study Director, Mesoblast, Inc.
    • Overall Contact(s)
      • Elizabeth Burke, ANP-C, 646-315-1725, elizabeth.burke@mesoblast.com

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