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Clinical trialNCT04549285WithdrawnPhase 1Interventional

Infusions of Mesenchymal Stromal Cells in Children With Multisystem Inflammatory Syndrome

SponsorJoanne Kurtzberg, MDEnrollment0Multisystem Inflammatory Syndrome in Children
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this multi-site, pilot study is to test whether infusions of human cord tissue mesenchymal stromal cells (hCT-MSC) are safe in children with multi system inflammatory syndrome (MIS-C). We will also describe the symptom course and duration of this hyper-inflammatory syndrome in these patients. Six patients less than 21 years old with MIS-C that is refractory to intravenous immune globulin (IVIG) and/or steroids will be given intravenous infusions of hCT-MSCs. Doses of 2x10\^6 cells/kg (up to a maximum dose of 100x10\^6 cells) will be given on days 1, 2, 3, +/-7 (day 7 is optional). Participants will be followed up to 90 days after administration for severe adverse events and survival. Safety will be evaluated through adverse event monitoring, clinical evaluations (i.e., vital signs, physical examinations), laboratory tests (i.e., hematology, serum chemistries, and urinalysis), and cardiac function (i.e., echocardiogram, ECG) from the signing of informed consent and throughout the patient's participation in this treatment protocol.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Emory University School of Medicine

    Atlanta, Georgia, United States

  • New York Medical College, Westchester Medical Center (wmc)

    Westchester, New York, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Human Cord Tissue Mesenchymal Stromal Cells
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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
12 Mar 2021
Primary completion
1 Feb 2022
Completion
1 Feb 2022
Last update posted
14 Sept 2021
Registered enrollment
0
Registry id
NCT04549285

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.