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 | Unknown

• 1 other identifier: MSB-MSC-MISC001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

MIS-C; COVID-19; MSC; remestemcel-L; Mesoblast; mesenchymal; cellular therapy; cells

Interventions

Remestemcel-L BIOLOGICAL

Participants may receive up to 2 infusions of 2 x 10\^6 remestemcel-L within a 5-day period.

Hydrocortisone DRUG

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.

Diphenhydramine DRUG

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.

Also known as: Benadryl®

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mesoblast International Sàrl: lead

Related Publications (1)

• Eckard AR, Borow KM, Mack EH, Burke E, Atz AM. Remestemcel-L Therapy for COVID-19-Associated Multisystem Inflammatory Syndrome in Children. Pediatrics. 2021 May;147(5):e2020046573. doi: 10.1542/peds.2020-046573. Epub 2021 Feb 12.

  PMID: 33579813 RESULT

MeSH Terms

Conditions

pediatric multisystem inflammatory disease, COVID-19 related; COVID-19

Interventions

remestemcel-l; Hydrocortisone; Diphenhydramine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kenneth M. Borow, MD

  Mesoblast, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Last Updated: October 31, 2025

Record last verified: 2025-10