ARTCLINE achieves milestone in septic shock: Patient recruitment for the ReActIF-ICE study successfully completed

ARTCLINE achieves milestone in septic shock:
Patient recruitment for the ReActIF-ICE study successfully completed

• Immune cell-based ARTICE^® therapy to support the dysregulated immune system in septic shock
• Recruitment of 142 patients completed; 90-day follow-up period underway and will be followed by the evaluation of the ReActIF-ICE study
• Presentation of results planned for the DIVI Congress (Dec. 2–4, 2026, Hamburg)

Rostock (Germany), April 14, 2026 – ARTCLINE, a biomedical company focused on the development of novel immune cell therapies for the treatment of septic shock, today announced the successful completion of patient recruitment for its ReActIF-ICE study (NCT05442710). A total of 142 patients were enrolled in the multicenter, randomized, controlled clinical trial. The study is evaluating the clinical benefit of the ARTICE^® therapy, which uses immune cells from healthy donors to relieve and regenerate the compromised immune system of patients with septic shock.

Jens Altrichter, MD, founder and Managing Director of ARTCLINE GmbH, commented: “We are very pleased with the strong commitment shown by the 20 leading intensive care centers that have used our ARTICE^® therapy as part of the study. The enrollment of the last patient marks an important milestone for ARTCLINE: With the collection of additional safety and mortality data, we have come a significant step closer to our goal of establishing a new therapeutic option for patients with septic shock. With ARTICE^®, we aim to reduce mortality associated with septic shock. We look forward to the final study data with great confidence and plan to present the results at Germany’s largest intensive care medicine congress, which will draw more than 7,000 participants.”

The need for new treatment options for sepsis remains high. Globally, approximately one in five deaths is associated with sepsis, as noted in a study on the burden of disease published in The Lancet.¹ Dirk Hessel, Managing Director of ARTCLINE GmbH, stated: “Given the high unmet need, the clinical evaluation of new therapeutic approaches is becoming increasingly important. With the completion of patient recruitment, we have taken a major leap forward in the development of our ARTICE^® therapy for the treatment of one of the most complex and deadly clinical conditions in medicine. We thank our study centers, partner hospitals, and the dedicated study team for their outstanding work and commitment.”

The principal investigator of the ReActIF-ICE study, Prof. Daniel A. Reuter, MD, of the Department of Anesthesiology, Intensive Care Medicine, and Pain Management at the University Medical Center Rostock, Germany, said: “The University Medical Center Rostock enrolled 31 patients in the ReActIF-ICE study and gained valuable practical experience in the application of this extracorporeal immune cell therapy. We recognize the potential clinical benefits of the ARTICE^® therapy and are convinced of the great promise this innovative treatment approach holds. Therapeutic options for patients with septic shock remain limited. This is an important new approach that specifically supports the patient’s dysregulated immune system and addresses complications such as secondary infections.”

About the ReActIF-ICE Study (NCT05442710)

The ReActIF-ICE study is a multicenter, randomized, controlled validation study involving 142 patients. The control group receives the current standard of care, while the treatment group receives up to six ARTICE^® immune cell treatments over a period of nine days in addition to standard of care. The primary endpoint of the study is safety and tolerability of the ARTICE^® therapy, measured by the occurrence of new serious adverse events (SAEs) up to Day 28. Secondary endpoints include, among others, overall mortality at Day 28, Day 90, and at hospital discharge, as well as daily changes in the SOFA score (Sequential Organ Failure Assessment). The 90-day follow-up period is well established in sepsis and serves to detect secondary infections, which are frequently associated with recurrent organ failure and increased mortality.

Patient recruitment for the study has been completed. The follow-up phase is currently ongoing at the 20 study centers. Data analysis is expected to follow; a presentation of the study results is planned for the DIVI Congress in December 2026.

About Sepsis and Septic Shock

Despite continuous advances in research and medicine, the mortality rate associated with sepsis remains high. According to the WHO, approximately 48 million people suffer from sepsis each year, including about 20 million children under the age of five. It is estimated that one in five deaths worldwide is associated with sepsis.¹ In Germany alone, between 70,000 and 220,000 people die from sepsis each year, about 200 to 600 deaths per day.² Dysregulation of the immune system plays a central role in the course of the disease, particularly in the most severe form of sepsis, septic shock. While many patients survive the initial phase of septic shock thanks to modern intensive care measures, serious complications such as secondary infections and recurrent organ failure frequently occur later on, contributing significantly to the high mortality rate.

About ARTCLINE GmbH

ARTCLINE GmbH develops novel immune cell therapies for use in critical care medicine. The company focuses on the treatment of septic shock – one of the major challenges for global health systems. With the ARTICE^® therapy, ARTCLINE uses allogeneic immune cells from healthy donors to specifically support and stabilize key functions of patients’ dysregulated immune systems. The therapeutic approach was developed in close collaboration with immunologists and clinical specialists.

All essential components of the ARTICE^® therapy, including the donor immune cells, as well as the systems and materials used, have received the necessary regulatory approvals (GMP manufacturing authorization and CE marking).

For more information, please visit www.artcline.de or contact info@artcline.de. Follow ARTCLINE on LinkedIn.
 

^[1]  Rudd K, Johnson S, Agesa K et al. Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. The Lancet 2020; 395, 200-211. DOI: 10.1016/S0140-6736(19)32989-7

^[2]  Institute for Health Metrics and Evaluation, University of Oxford http://ihmeuw.org/7cpk
 

Contact:       
ARTCLINE GmbH     
Dirk Hessel, Managing Director     
dirk.hessel@artcline.de     

       

Media inquiries:
MC Services AG
Eva Bauer / Julia von Hummel
Phone: +49-89-210228-0
artcline@mc-services.eu