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Experimental stem cells offered to kids with rare COVID complication

NCT ID NCT04456439

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study provides early access to an experimental stem cell treatment called remestemcel-L for children aged 2 months to 17 years with MIS-C, a severe inflammatory condition linked to COVID-19. The treatment aims to calm the immune system and reduce inflammation. Participants receive up to two infusions of the cells, along with standard medicines to prevent allergic reactions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remestemcel-L (human mesenchymal stromal cells)
What this could lead to
If successful, this could provide a treatment option for children with severe MIS-C, a rare but serious inflammatory condition linked to COVID-19.
What could go wrong
This is an expanded access program, not a full clinical trial, so results are limited. The number of participants is small, and the therapy may not work for all children or could cause side effects like allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months to 17 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 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. Body mass index (BMI) ≥40 kilograms per square meter (kg/m\^2) 4. Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins 5. Aspartate aminotransferase/alanine transaminase (AST/ALT) ≥5x upper limit of normal (ULN) 6. Creatinine clearance \<30 mL/min 7. Serum creatinine \>2 mg/dL 8. Any end-stage organ disease which in the opinion of the treating physician may possibly affect the safety of the remestemcel-L treatment.

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Conditions

The condition(s) this trial relates to.

COVID-19 COVID-19–associated multisystem inflammatory syndrome in children pediatric multisystem inflammatory disease, COVID-19 related

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.