The results of Part II of the current “EISS-1” study were published today in the journal BioMed Research International. The purpose of the study was to determine safety of ARTCLINE’s immune cell-based extracorporeal therapy for the treatment of patients with severe infections (sepsis).
The aim of the study was to use donor immune cells, so-called granulocyte concentrates, in patients with septic shock and immune dysfunction in a strictly extracorporeal environment in the sense of “immune dialysis” and thereby prevent possible local side effects in the inflamed tissue.
The results of Part I of the current clinical study were already published in 2011 in the journal Critical Care. The outcomes were i.e. a good tolerability in critically ill patients with septic shock, a significant improvement in the hemodynamic shock situation as well as the improvement in the infection and immune situation.
This follow-up study or the current Part II for the treatment of additional 10 patients with a higher immune cell concentration has now also been successfully completed.
In summary, there are also three main statements (based on the results of the available studies):
- extracorporeal granulocyte treatment led to immunomodulation and a reduction of norepinephrine-dosage in patients during extracorporeal therapy;
- the treatment was well tolerated and
- a positive impact on the viability and function of hepatocyte senor cells (hepatotoxicity test of patient’s plasma) were seen during the extracorporeal treatments.
Dr. Jens Altrichter, physician and CEO of ARTCLINE GmbH and Prof. Steffen Mitzner from the Rostock University Medical Center and head of this clinical study, are happy about the excellent results of the study. The two medical professionals agree that further studies should focus on changes in the hemodynamic system, immune function, and other organ functions in septic patients. “Extracorporeal therapies have long been used to treat individual organ failure in sepsis. With the immune cell dialysis developed by ARTCLINE and successfully tested, the patient’s immune system could be reactivated to overcome the sepsis. This type of therapy could have a positive impact on the survival of patients with severe sepsis.” says Dr. Altrichter.
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