NCT04549285|WithdrawnPhase 1DMCFDA Drug
Study Stopped
No accrual
Loading search results
No accrual
MISTIC
A Phase I Pilot Study of the Safety of Infusions of Allogeneic Human Cord Tissue Mesenchymal Stromal Cells in Children With Multisystem Inflammatory Syndrome in Children (MIS-C)
Sponsor study identifier
interventional
0
1 country
3
Study Start
March 12, 2021
Actual (reported)Primary Completion
February 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 8, 2020
Actual (reported)September 16, 2020
Actual (reported)March 12, 2021
Actual (reported)February 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Safety of the Investigational Product, hCT-MSCs, infusion reactions
Incidence of infusion reactions
2 days post infusion
Safety of the Investigational Product, hCT-MSCs, related adverse events
Incidence of later reactions attributed to the investigational product
90 days post initial infusion
Safety of the Investigational Product, hCT-MSCs, anti-HLA antibodies
Incidence of formation of new anti-HLA antibodies post infusion as compared to pre-infusion levels.
from first dose of MSCs to 28 days after first dose
Survival
from first dose of MSCs to 28 days after first dose
Inotrope support
from first dose of MSCs to 90 days after first dose
Hospital Discharge
from first dose of MSCs to 90 days after first dose
Duration of ICU stay
from first dose of MSCs to 90 days after first dose
cardiac abnormalities
from first dose of MSCs to 28 days after first dose
Doses will be given on days 1, 2, 3, and a fourth, optional dose may be given on day 7 at the discretion of the investigator and the treating physician.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
New York Medical College, Westchester Medical Center (WMC)
Westchester, New York, 10595, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Joanne Kurtzberg, MD
Duke University
0 participants (actual enrollment reported by the registry).
First Submitted
September 8, 2020
First Posted
September 16, 2020
Study Start
March 12, 2021
Actual (reported)Investigation of Prognostic Biomarkers, Host Factors and Viral Factors for COVID-19 in Children
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 14, 2021
Record last verified: 2021-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: