Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy

Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy (NCT05442710) is a Phase 2 interventional studying Sepsis, Severe, sponsored by Artcline GmbH. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care. This may contribute to the improvement of the impaired organ function of septic shock patients by assisting the impaired immune system (immune competence enhancement = ARTICE)

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Sepsis, Severe and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 142 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Sepsis, Severe subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adult subjects 1. ≥ 18 years of age 2. with septic shock, defined as those with septic shock according to" Sepsis-3-Definition" who additionally require norepinephrine at a dose of ≥ 0.15 mcg/kg/min (and/or vasopressin at any dose) for a minimum of 6 hours (within the last 48 hours), to maintain a MAP ≥65 mmHg 3. Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of \<5 to be enrolled. 2. Fulfillment of the definition of septic shock, not longer than 48h before randomization. I.e. the 48h start at the end of the 6h period. 3. Blood lactate \>2 mmol/L despite adequate volume resuscitation during the current sepsis episode 4. Source control achieved / in progress in the judgement of the investigator 5. Subjects are required to have central venous access and an arterial line, and these are expected to remain present for at least the initial 48 hours of study. 6. Subjects must have received adequate volume replacement in the judgement of the investigator. 7. Subject or legal surrogate is willing and able to provide written willing to sign a consent form and comply with all protocol requirements or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include subjects who are unable to provide willing to sign a consent form. Who Should NOT Join This Trial: 1. Acute or chronic leukemia, 2. Bilirubin ≥ 2 mg/dL (≥33 µmol/L), 3. Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy, 4. autoimmune conditions (where your immune system attacks your own body) with systemic medication of ≥10 mg prednisolone equivalent, 5. Previous transplantation, 6. Subjects receiving interferon therapy (14 days prior randomisation), 7. Acute pulmonary embolism within the last 72 hours, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Adult subjects 1. ≥ 18 years of age 2. with septic shock, defined as those with septic shock according to" Sepsis-3-Definition" who additionally require norepinephrine at a dose of ≥ 0.15 mcg/kg/min (and/or vasopressin at any dose) for a minimum of 6 hours (within the last 48 hours), to maintain a MAP ≥65 mmHg 3. Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of \<5 to be enrolled. 2. Fulfillment of the definition of septic shock, not longer than 48h before randomization. I.e. the 48h start at the end of the 6h period. 3. Blood lactate \>2 mmol/L despite adequate volume resuscitation during the current sepsis episode 4. Source control achieved / in progress in the judgement of the investigator 5. Subjects are required to have central venous access and an arterial line, and these are expected to remain present for at least the initial 48 hours of study. 6. Subjects must have received adequate volume replacement in the judgement of the investigator. 7. Subject or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include subjects who are unable to provide informed consent. Exclusion Criteria: 1. Acute or chronic leukemia, 2. Bilirubin ≥ 2 mg/dL (≥33 µmol/L), 3. Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy, 4. Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent, 5. Previous transplantation, 6. Subjects receiving interferon therapy (14 days prior randomisation), 7. Acute pulmonary embolism within the last 72 hours, 8. Ischemic stroke or intracranial bleeding within the last 3 months 9. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG within the last 72 hours, 10. Cardiopulmonary resuscitation within last 7 days, 11. Moribund subject (life expectancy \<72 hours), in the judgement of the investigator 12. Presence of a do-not-resuscitate or do-not-intubate order, 13. Known HIV infection or chronic viral hepatitis, 14. Isolated Urosepsis, 15. Pregnancy/nursing period, 16. Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock), 17. Previous sepsis with ICU admission within this hospital stay, 18. Known/suspected acute mesenteric ischaemia, 19. Chronic mechanical ventilation for any reason OR severe COPD requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days, 20. Decision to limit full care taken before obtaining informed consent, 21. Prior enrolment in the trial, 22. Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or device, 23. multiple injuries including polytrauma and burn \>20% TBSA (2° or 3°), 24. Diagnosed and documented pre-existing dementia, 25. Severe Covid-Pneumonia

Treatments Being Tested

BIOLOGICAL

ARTICE

Extracorporal treatment with purified granulocyte concentrate

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Universitätsklinikum Freiburg, Interdisziplinäre Medizinische Intensivtherapie (IMIT)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Regensburg, Klinik für Anästhesiologie

Regensburg, Bavaria, Germany

Universitätsklinikum Bonn, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Köln, Klinik für Anästhesiologie und Operative Intensivmedizin

Cologne, North Rhine-Westphalia, Germany

Helios Klinikum Aue

Aue, Saxony, Germany

Universitätsklinikum Leipzig, Klinik und PK für Anästhesiologie und Intensivtherapie

Leipzig, Saxony, Germany

Universitätsklinikum Halle (Saale), Universitätsklinik für Anästhesiologie und Operative Intensivmedizin

Halle, Saxony-Anhalt, Germany

UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, Germany

Charité Berlin, Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin

Berlin, Germany

Klinikum Braunschweig, Medizinische Klinik V

Braunschweig, Germany

Universitätsklinikum Essen, Klinik für Nephrologie

Essen, Germany

University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy

Frankfurt, Germany

Helios Klinikum HIldesheim

Hildesheim, Germany

Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin

Magdeburg, Germany

University Medical Center Mainz, Study center for Anesthesiology

Mainz, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

University Hospital Minden, Departmenr of Anaesthesiology, intensive and emergency care

Minden, Germany

Klinikum Oldenburg, Universitätsklinik für Anästhesiologie/ Intensivmedizin

Oldenburg, Germany

Universitätsmedizin Rostock, Abteilung KAI

Rostock, Germany

Helios Kliniken Schwerin, Department for intensive care

Schwerin, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05442710), the sponsor (Artcline GmbH), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05442710 clinical trial studying?

Who can participate in NCT05442710?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05442710?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05442710. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05442710. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.