As of today, ARTCLINE received the grant notification over EUR 212,500 from the Federal Ministry of Education and Research (BMBF). As part of the project “Extracorporeal immune cell therapy to restore patient health after an acute Immune failure in sepsis (ReActiF-ICE)”, a clinical multicenter study will be prepared.
The BMBF supports innovative and high-risk research projects by small and medium-sized enterprises (SMEs), in order to create the basis for later product development and clinical research.
ARTCLINE’s extracorporeal immune cell therapy combines medical device technology, adapted from kidney dialysis with immune cells from healthy blood donors for the treatment of severe Infections (sepsis).
The program of the BMBF supports ARTCLINE in the preparation of a randomized, controlled clinical trial with more than 100 patients with septic shock. All regulatory requirements shall be identified, and the necessary study documentation will be compiled, based on previous research and development projects.
Sepsis, the most severe form of acute infection, is a significant challenge to health care systems around the world. It is the third most common cause of death. The cause of sepsis is a misdirected immune reaction to a mostly bacterial infection. At the beginning there is an immune overreaction, mostly followed by an immune failure. According to a German Sepsis Association (Deutsche Sepsis-Hilfe), more than 60,000 patients in Germany die every year as a result of this disease. Despite numerous research and development in the field of medical technology or pharmacy, the treatment of patients with sepsis remains one of the greatest medical and health economic challenges worldwide.
Actually, ARTCLINE plans to carry out the randomized, controlled clinical trial in intensive care units in 4 German hospitals. The aim of the study is to demonstrate not only the safety but also the efficacy of ARTCLINE’s extracorporeal immune cell therapy.
The project ends with the final approval of the clinical study.
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