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

NCT04456439 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-10-31

No results posted yet for this study

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.

Conditions

  • Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

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.

Sponsors & Collaborators

  • Mesoblast International Sàrl

    lead INDUSTRY

Principal Investigators

  • Kenneth M. Borow, MD · Mesoblast, Inc.

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456439 on ClinicalTrials.gov