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.

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.

All 10 study subjects survived while matched historical controls had a mortality rate of 27%.

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