Status:
NO_LONGER_AVAILABLE
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
Lead Sponsor:
Mesoblast International Sàrl
Conditions:
Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
Eligibility:
All Genders
2-17 years
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- 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
- If on mechanical ventilation or ECMO, ≤72 hours post initiation of the respiratory support device
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04456439
Last Update
October 31 2025
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