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Infusions of Mesenchymal Stromal Cells in Children With Multisystem Inflammatory Syndrome

NCT04549285 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-09-14

No results posted yet for this study

Summary

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.

Conditions

  • Multisystem Inflammatory Syndrome in Children

Interventions

BIOLOGICAL

Human Cord Tissue Mesenchymal Stromal Cells (hCT-MSCs)

Human Umbilical Cord Tissue-derived Mesenchymal Stromal Cells (hCT-MSC): hCT-MSCs is an allogeneic cell product manufactured from donated umbilical cord tissue that is digested and expanded in culture, cryopreserved and banked. Doses contain 2x10\^6 cells/kg (up to a maximum dose of 100x10\^6 cells) diluted in plasmalyte-A with 5% HSA to a volume of 20-40mL.

Sponsors & Collaborators

  • Joanne Kurtzberg, MD

    lead OTHER

Principal Investigators

  • Joanne Kurtzberg, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04549285 on ClinicalTrials.gov