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
  • Evidence of clinically severe multisystem illness requiring hospitalization. Participants must have demonstrable cardiac involvement (reduced left ventricular [LV] ejection fraction ≤50%) and at least one other organ involvement (renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological)

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. Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins

4. Aspartate aminotransferase/alanine transaminase (AST/ALT) ≥5x upper limit of normal (ULN)

5. Creatinine clearance <30 mL/min

6. Serum creatinine >2 mg/dL

7. 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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