Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients

PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study

The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.

Inclusion Criteria:

• sepsis with at least one organ failure (severe sepsis) or septic shock

Exclusion Criteria:

• Participation in another study within the last 30 days
• Earlier participation in this study
• Pregnancy
• Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
• Hemodynamic shock for more than 12 hours (systolic BP <90mmHg) despite adequate therapy
• HIV infection
• HCV infection, active