Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)NCT04456439
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
A study testing Remestemcel-L, Hydrocortisone and Diphenhydramine in people with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19), run by Mesoblast International Sàrl.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
- What is being tested?
- Remestemcel-L, Hydrocortisone and Diphenhydramine
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 17 years
- All sexes
- Child
Who may be able to join
- 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)
Show all 21Show fewer
- 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
Who cannot join
- 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.
About this study
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)
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.
Read the 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.
- Conditions
- Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
- Being tested
- Remestemcel-L, Hydrocortisone, Diphenhydramine
- Keywords
- MIS-C, COVID-19, MSC, remestemcel-L, Mesoblast, mesenchymal, cellular therapy, cells
- Medical subject headings
- pediatric multisystem inflammatory disease, COVID-19 related, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remestemcel-LBiological
Participants may receive up to 2 infusions of 2 x 10^6 remestemcel-L within a 5-day period.
HydrocortisoneDrug
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.
DiphenhydramineDrug
Also called Benadryl®
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Mesoblast International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth M. Borow, MD, Study director, Mesoblast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456439
- Sponsor's protocol ID
- MSB-MSC-MISC001
- Status last verified
- Oct 2025
- First submitted
- 29 Jun 2020
- Last updated
- 31 Oct 2025
- Results posted
- No
Publications
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.
PubMed 33579813
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04456439
- Acronym / sponsor ID
- MSB-MSC-MISC001
- 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
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Mesoblast International SàrlIndustry (pharma, biotech, devices)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (21 listed)
- 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:
- If on mechanical ventilation or ECMO, ≤72 hours post initiation of the respiratory support device
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remestemcel-LParticipants may receive up to 2 infusions of 2 x 10^6 remestemcel-L within a 5-day period. | Biological | – |
| HydrocortisoneParticipants 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 | – |
| DiphenhydramineAlso: Benadryl®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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Results publication: PubMed 33579813Eckard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M. Borow, MD study director
Mesoblast, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Remestemcel-L, Hydrocortisone and Diphenhydramine in people with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19), run by Mesoblast International Sàrl.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04456439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.