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

NCT05442710 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-05-25

No results posted yet for this study

Summary

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)

Conditions

  • Sepsis, Severe

Interventions

BIOLOGICAL

ARTICE

Extracorporal treatment with purified granulocyte concentrate

Sponsors & Collaborators

  • Zentrum für Klinische Studien Jena

    collaborator OTHER

  • RQM+

    collaborator INDUSTRY

  • Artcline GmbH

    lead INDUSTRY

Principal Investigators

  • Daniel Reuter, Prof.Dr. · University Hospital Rostock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-24
Primary Completion
2026-03-30
Completion
2026-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442710 on ClinicalTrials.gov