Stopped: Funding Decision
Bacterial sepsis occurs in patients with severe infections. The condition is caused by toxic substances (toxins) released from bacteria and the patient's elevated inflammatory response to those toxins. In preclinical studies, human mesenchymal stromal cells (MSCs) have been proven to modulate host inflammation in infections, including sepsis. The purpose of the Phase I, open label, dose escalation safety trial is to determine whether escalating doses of enhanced MSCs (GEM00220) are safe and well tolerated in patients with septic shock.
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The safety of GEM00220 will be assessed by monitoring adverse events
Timeframe: Baseline to 28 days
Maximum Feasible Tolerated Dose
Timeframe: Baseline to 28 days