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Background. Sepsis has no proven specific pharmacologic treatment. Reported mortality in sepsis ranges from 30%-45%. This study was designed to determine the safety preliminary efficacy of allogenic apoptotic cells administered for immunomodulation in septic patients. Methods. The primary aim of this phase IB study was to determine the safety profile of apoptotic cell infusion in subjects presenting to the emergency room with sepsis. Sepsis was determined by clinical infections and Sequential Organ Failure Assessment (SOFA) scores >2. The secondary aims were to measure organ dysfunction, intensive care unit (ICU) and hospital stays, and mortality, that were compared to historical controls. Exploratory endpoints included measuring immune modulator agents to elucidate the mechanism of action using Luminex(R) analysis. Findings. Ten patients were treated with apoptotic cells, administered as a single dose or two sequential doses. All 10 patients had mild-to-moderate sepsis with a SOFA score range of 2-6 upon entering the study. No serious adverse events (SAEs) and no related AEs were reported. All 10 study subjects survived while matched historical controls had a mortality rate of 27%. The study subjects exhibited rapid resolution of organ dysfunction and had significantly shorter ICU lengths of stay compared to matched historical controls (p<0.0001). All patients had both elevated pro- and anti-inflammatory cytokines, chemokines and additional immune modulators that gradually decreased following treatment. Interpretation. Administration of apoptotic cells to patients with mild-to-moderate sepsis was safe and had a significant immuno-modulating effect, leading to early resolution of the cytokine storm. Trial registration. ClinicalTrials.gov Identifier: NCT03925857 Funding. The study was sponsored by Enlivex Therapeutics Ltd.
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10.1101/2020.12.03.20242586
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document_parses/pdf_json/f29b4aef4960dbf5adfbc9ed2dab967cb8346200.json
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Apoptotic cells for therapeutic use in cytokine storm associated with sepsis
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