ARTCLINE GmbH, a privately owned clinical stage company combining Medtech and Biotech, published the results of a clinical phase I / II study demonstrating application safety and efficacy indications of its immune cell-based extracorporeal therapy for the treatment of patients with severe infections (sepsis).
In 1998, the concept of an immune cell-based extracorporeal therapy was presented for the first time and subsequently tested in animal models on rats and pigs. The results of both studies have been published already. The data showed significant improvements due to extracorporeal therapy with donor immune cells.
Due to the promising results, ARTCLINE, in cooperation with the University of Rostock, started a phase I / II study to demonstrate safety and effectiveness of the use of granulocyte concentrates in extracorporeal blood circulation devices – the so-called “EISS-1” study.
The results of the clinical study were published in the journal Critical Care today. The aim of the study was to use immune cells from healthy blood donors, 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.
Conclusions of the study:
- Extracorporeal plasma-treatment with granulocytic cells is well tolerated in critically ill patients with septic shock;
- Treatment was associated with significant improvement of the hemodynamic situation of the patients, and
- Clinical courses of the patients in this pilot study encourage further clinical studies with this therapeutic approach.
A follow-up study on the treatment of additional 10 patients with a higher immune cell concentration began already in 2010. A publication of the results of this follow-up study is planned. We keep visitors of our website up to date in our NEWS.
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