Immune Modulation by Exosomes in COVID-19

Recruiting

• Conditions: Critical Illness; COVID-19; Hypercytokinemia; Lung Fibrosis

• Registration Number: NCT05191381
• Lead Sponsor: University of Ulm

Brief Summary

Following whole blood stimulation with mesenchymal stem cell derived exosomes, immune phenotype, cytokine release and mRNA expression patterns from critically ill patients with COVID-19 will be determined.

Detailed Description

Critically ill patients with COVID-19 may develop lung failure and require extracorporal oxygenation due to hyperinflammation and progressive lung fibrosis. The anti-inflammatory and immune modulatory function of mesenchymal stem cells will be investigated by whole blood stimulation experiments using stem cell derived exosomes. Exosome preparations have been characterized by miRNA and protein expression patterns and suggest their tissue regenerative capacity.

The hypothesis of the present study is that mesenchymal stem cell derived exosomes attenuate inflammation and support anti-fibrotic pathways.

Study Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Primary Completion: 2025-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Critically ill COVID-19 patients with lung dysfunction
• COVID-19 WHO severity degree >= 4, ARDS (WHO Definition 13 March 2020)
• Body weight > 50 kg
• Informed consent

Exclusion Criteria

• Pregnant or breast feeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cytokine profile in supernatants	24 hours, 1 year	Quantification of pro- and anti-inflammatory biomarkers after 24 hours of whole blood culture

Secondary Outcome Measures

Name	Time	Method
Immune phenotyping	1 year	Immune phenotypes related to type I interferon signaling
Genetic predisposition to hyperinflammation	1 year	Determination of functional single nucleotide polymorphisms of inflammatory genes and receptors

Trial Locations

Locations (1)

Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine; 🇩🇪 Ulm, Germany