Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
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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.
Participants may receive up to 2 infusions of 2 x 10^6 remestemcel-L within a 5-day period.
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
2 Months to 17 Years (Child)
Sexes Eligible for Study:
2 months to 17 years of age, inclusive
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
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 lactic dehydrogenase (LDH)
elevated interleukin 6 (IL-6)
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
If on mechanical ventilation or ECMO, ≤72 hours post initiation of the respiratory support device
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.
Females who are pregnant or lactating
Body mass index (BMI) ≥40 kilograms per square meter (kg/m^2)
Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
Aspartate aminotransferase/alanine transaminase (AST/ALT) ≥5x upper limit of normal (ULN)
Creatinine clearance <30 mL/min
Serum creatinine >2 mg/dL
Any end-stage organ disease which in the opinion of the treating physician may possibly affect the safety of the remestemcel-L treatment.