Grant: Operating Grant

Severe infection with shock (septic shock) in the intensive care unit (ICU) is common accounting for approximately 20% of admissions, of which 40% will die. Septic shock is associated with an immensely uncontrolled inflammatory response from the body that is initiated by the infectious organism. Recent studies done in animals with sepsis suggest that the infusion of stem cells may balance inflammation, help with repair of injured organs, and reduce death. Hence, it represents an exciting and promising potential therapy for septic shock. Cellular therapy has not yet been tested in humans with septic shock and so the safety and optimal dose of these cells is yet to be established. This is the primary purpose of the CISS Phase I Trial. The CISS Phase I Trial will enroll 2 groups of patients with septic shock. One group will not receive the cells (control group), but will serve as a comparison group to those who do. The second group will receive increasing doses of cell therapy. Three patients per group will form the low dose, mid dose, and high dose groups. The frequency of adverse events and serious adverse events will be recorded, and blood will be drawn repeatedly over time for inflammation markers in the control and cell therapy groups. Careful monitoring by an independent and expert committee will review the occurrence of adverse events after the completion of each cell dose group. Carefully defined rules for stopping the trial in the case of serious adverse events that are linked the infusion of these cells will be strictly adhered to. If the CISS Phase I Trial determines that treatment with these cells is safe, then the optimum dose of cells established by this Phase I Trial will be used in a subsequent study to determine whether these cells improve patient outcomes.