Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
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.
Description: Incidence of infusion reactions
Measure: Safety of the Investigational Product, hCT-MSCs, infusion reactions Time: 2 days post infusionDescription: Incidence of later reactions attributed to the investigational product
Measure: Safety of the Investigational Product, hCT-MSCs, related adverse events Time: 90 days post initial infusionDescription: Incidence of formation of new anti-HLA antibodies post infusion as compared to pre-infusion levels.
Measure: Safety of the Investigational Product, hCT-MSCs, anti-HLA antibodies Time: from first dose of MSCs to 28 days after first doseDescription: Survival rate at 28 days after the first dose of MSCs
Measure: Survival Time: from first dose of MSCs to 28 days after first doseDescription: Description of duration of inotrope support after the first dose of MSCs
Measure: Inotrope support Time: from first dose of MSCs to 90 days after first doseDescription: Description of number of days to hospital discharge to home
Measure: Hospital Discharge Time: from first dose of MSCs to 90 days after first doseDescription: Description of Duration of ICU stay
Measure: Duration of ICU stay Time: from first dose of MSCs to 90 days after first doseDescription: Incidence of cardiac abnormalities at day 28, defined as persistent abnormalities in ECG, Echo, or biochemical markers (pro-BNP, troponin).
Measure: cardiac abnormalities Time: from first dose of MSCs to 28 days after first doseAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports