Clinical Newswire, March 12, 2010 (Munich, Germany) - An extracorporeal immune support system (EISS) developed by researchers from the University of Rostock, Germany, was found to be safe in patients with septic shock in a first-in-man trial. Significant reductions in circulating bacterial endotoxins and other parameters were also observed. The results were presented on March 11th at the 8th World Congress on Trauma, Shock, Inflammation and Sepsis, Munich, Germany.
Neutrophils and other granulocytes constitute the first line of defence against bacterial infections. In severe sepsis, host defences are overwhelmed and high levels of bacterial endotoxins circulate, causing organ failure and death. However, since granulocytes are also involved in inflammation and local tissue damage, direct transfusions can cause harm.
An extracorporeal granulocyte-based system for the treatment of plasma was therefore developed, as it was thought that this would provide benefit without the risk of tissue damage side effects. The EISS is a bioreactor containing around 1.5 x 1010 granulocytes from healthy donors. Previous pig studies showed significant improvements in sepsis survival times conferred by EISS treatment.
In the current study 10 consecutive patients with septic shock were recruited at the University of Rostock hospital ICU. On ICU admission, the patients’ mean APACHE II score was 30, and mean SAPS II score was 66. Each patient was treated with the EISS in two 6 hr sessions within 72 hours. An average of ten litres of plasma from each patient was treated. Patients were followed up for 28 days, with assessment of tolerance and technical safety, organ function and survival. Plasma parameters were also measured.
The results of the first trial in humans were positive, with EISS treatment being well tolerated. Significant reductions in plasma bacterial endotoxin concentrations were observed. In addition, C-reactive protein, procalcitonin and HLA-DR parameters showed significant improvements following EISS treatment. Finally, the researchers noted that noradrenaline requirements for maintaining a stable mean arterial pressure were reduced in the ten patients.
Whilst the primary end-point was safety, ‘a further intention was to find suitable efficacy end points for subsequent controlled trials,’ commented investigator Martin Sauer. Given the promising preliminary results of the EISS, further trials for efficacy on a larger scale are indicated.
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