NCT05191381

Immune Modulation by Exosomes in COVID-19

Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Critical Illness
• Hypercytokinemia
• Lung Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	Application of exosomes in a whole blood assay	Co-incubation of patient-derived whole blood samples with mesenchymal stem cell derived exosomes and read-out of biomarkers, RNA and immune phenotypes after 24h.

Timeline

• Start date: 2021-12-22
• Primary completion: 2025-07-31
• Completion: 2026-12-31
• First posted: 2022-01-13
• Last updated: 2024-01-17

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study