Official Title
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)
Brief Summary

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.

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.

Available
Intermediate-size Population
Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

Biological: Remestemcel-L
Participants may receive up to 2 infusions of 2 x 10^6 remestemcel-L within a 5-day period.
Other Name: Ryoncil™

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.
Other Name: Benadryl®

Eligibility Criteria

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 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.

Eligibility Gender
All
Eligibility Age
Minimum: 2 Months~Maximum: 17 Years
Contacts

Elizabeth Burke, ANP-C
646-315-1725
elizabeth.burke@mesoblast.com

Kenneth M. Borow, MD
610-299-7855
ken.borow@mesoblast.com

Kenneth M. Borow, MD
Study Director
Mesoblast, Inc.

Mesoblast International Sàrl
NCT Number
Keywords
MIS-C
Covid-19
MSC
remestemcel-L
Mesoblast
mesenchymal
Cellular therapy
cells
MeSH Terms
Coronavirus Infections
Syndrome
Diphenhydramine
Promethazine
Hydrocortisone