ARTCLINE Completes Patient Recruitment for Septic Shock Immune Cell Therapy Trial
核心洞察
ARTCLINE (搜索) successfully enrolled 142 patients in its ReActIF-ICE study evaluating ARTICE® (搜索) therapy, which uses immune cells from healthy donors to support compromised immune systems in septic shock (搜索) patients.
The multicenter, randomized controlled trial involves 20 leading intensive care centers and aims to establish a new therapeutic option for septic shock (搜索), a condition associated with one in five deaths globally.
The study's 90-day follow-up period is currently underway, with results planned for presentation at the DIVI Congress in December 2026.
ARTCLINE (搜索), a biomedical company focused on immune cell therapies for septic shock (搜索), announced the successful completion of patient recruitment for its ReActIF-ICE study (NCT05442710). The multicenter, randomized, controlled clinical trial enrolled 142 patients across 20 leading intensive care centers to evaluate the clinical benefit of ARTICE® (搜索) therapy, which uses immune cells from healthy donors to support the compromised immune systems of septic shock patients.
Novel Approach to Septic Shock Treatment
The ARTICE® (搜索) therapy represents an innovative extracorporeal immune cell treatment designed to address the dysregulated immune system (搜索) that characterizes septic shock (搜索). According to Prof. Daniel A. Reuter, MD, principal investigator of the ReActIF-ICE study and head of the Department of Anesthesiology, Intensive Care Medicine, and Pain Management at the University Medical Center Rostock (搜索), "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."
The University Medical Center Rostock (搜索) alone enrolled 31 patients in the study and gained valuable practical experience with the therapy. Prof. Reuter emphasized the potential clinical benefits of the ARTICE® (搜索) therapy and expressed conviction about the promise of this innovative treatment approach.
Study Design and Endpoints
The ReActIF-ICE study is structured as a multicenter, randomized, controlled validation study. The control group receives current standard of care, while the treatment group receives up to six ARTICE® (搜索) immune cell treatments over a nine-day period in addition to standard care. The primary endpoint focuses on safety and tolerability of the ARTICE® therapy, measured by the occurrence of new serious adverse events (SAEs) up to Day 28.
Secondary endpoints include 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, well-established in sepsis (搜索) research, serves to detect secondary infections, which are frequently associated with recurrent organ failure and increased mortality.
Addressing Critical Medical Need
The global burden of sepsis (搜索) remains substantial. According to data cited by ARTCLINE (搜索) from The Lancet, approximately one in five deaths worldwide is associated with sepsis. The WHO reports that approximately 48 million people suffer from sepsis each year, including about 20 million children under the age of five. In Germany alone, between 70,000 and 220,000 people die from sepsis annually, representing about 200 to 600 deaths per day.
Jens Altrichter, MD, founder and Managing Director of ARTCLINE (搜索) GmbH, commented on the milestone: "We are very pleased with the strong commitment shown by the 20 leading intensive care centers that have used our ARTICE® (搜索) 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 (搜索)."
Clinical Rationale and Mechanism
Dysregulation of the immune system (搜索) plays a central role in sepsis (搜索) progression, particularly in septic shock (搜索), the most severe form of the condition. 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, contributing significantly to high mortality rates.
The ARTICE® (搜索) therapy uses allogeneic immune cells from healthy donors to specifically support and stabilize key functions of patients' dysregulated immune systems. This therapeutic approach was developed through close collaboration with immunologists and clinical specialists.
Regulatory Status and Next Steps
All essential components of the ARTICE® (搜索) therapy, including the donor immune cells and the systems and materials used, have received necessary regulatory approvals, including GMP manufacturing authorization and CE marking.
Dirk Hessel, Managing Director of ARTCLINE (搜索) 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® (搜索) therapy for the treatment of one of the most complex and deadly clinical conditions in medicine."
The 90-day follow-up phase is currently ongoing at the 20 study centers. Data analysis is expected to follow, with a presentation of study results planned for the DIVI Congress in December 2026, Germany's largest intensive care medicine congress, which draws more than 7,000 participants.