Treatment for severe sepsis using immune cell therapy

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

This study tests a new immune cell therapy for adults with severe sepsis to see if it can help them recover better alongside standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Artcline GmbH (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 20 sites (Freiburg im Breisgau, Baden-Wurttemberg and 19 other locations)
• Trial ID: NCT05442710 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a novel therapy for patients suffering from severe sepsis. Participants will be randomized into a treatment group that receives an immune cell perfusion system in addition to standard care. The aim is to enhance immune competence and improve organ function in patients experiencing septic shock. The study focuses on adults who meet specific criteria related to their condition and treatment needs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are experiencing septic shock and require vasopressor support.

Not a fit: Patients who do not meet the criteria for septic shock or are unable to receive the necessary interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve recovery outcomes for patients with severe sepsis.

How similar studies have performed: While this approach is novel, similar studies exploring immune therapies in sepsis have shown promising results.

Eligibility criteria

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

Where this trial is running

Freiburg im Breisgau, Baden-Wurttemberg and 19 other locations

• Universitätsklinikum Freiburg, Interdisziplinäre Medizinische Intensivtherapie (IMIT) — Freiburg im Breisgau, Baden-Wurttemberg, Germany (Withdrawn)
• Universitätsklinikum Regensburg, Klinik für Anästhesiologie — Regensburg, Bavaria, Germany (Recruiting)
• Universitätsklinikum Bonn, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin — Bonn, North Rhine-Westphalia, Germany (Recruiting)
• Universitätsklinikum Köln, Klinik für Anästhesiologie und Operative Intensivmedizin — Cologne, North Rhine-Westphalia, Germany (Recruiting)
• Helios Klinikum Aue — Aue, Saxony, Germany (Recruiting)
• Universitätsklinikum Leipzig, Klinik und PK für Anästhesiologie und Intensivtherapie — Leipzig, Saxony, Germany (Recruiting)
• Universitätsklinikum Halle (Saale), Universitätsklinik für Anästhesiologie und Operative Intensivmedizin — Halle, Saxony-Anhalt, Germany (Recruiting)
• UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel — Kiel, Schleswig-Holstein, Germany (Recruiting)
• Charité Berlin, Klinik mit Schwerpunkt Nephrologie und internistische Intensivmedizin — Berlin, Germany (Recruiting)
• Klinikum Braunschweig, Medizinische Klinik V — Braunschweig, Germany (Recruiting)
• Universitätsklinikum Essen, Klinik für Nephrologie — Essen, Germany (Recruiting)
• University Hospital Frankfurt, Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy — Frankfurt, Germany (Not_yet_recruiting)
• Helios Klinikum HIldesheim — Hildesheim, Germany (Recruiting)
• Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin — Magdeburg, Germany (Recruiting)
• University Medical Center Mainz, Study center for Anesthesiology — Mainz, Germany (Recruiting)
• Universitätsklinikum Mannheim — Mannheim, Germany (Recruiting)
• University Hospital Minden, Departmenr of Anaesthesiology, intensive and emergency care — Minden, Germany (Recruiting)
• Klinikum Oldenburg, Universitätsklinik für Anästhesiologie/ Intensivmedizin — Oldenburg, Germany (Recruiting)
• Universitätsmedizin Rostock, Abteilung KAI — Rostock, Germany (Recruiting)
• Helios Kliniken Schwerin, Department for intensive care — Schwerin, Germany (Recruiting)

Study contacts

• Principal investigator: Daniel Reuter, Prof.Dr. — University Hospital Rostock
• Study coordinator: Jens Altrichter, MD

Conditions Sepsis, Severe