Immune Modulation by Exosomes in COVID-19

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05191381

Acronym

IMECOV19

Enrollment

Registered

2022-01-13

Start date

2021-12-22

Completion date

2026-12-31

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Critical Illness, Hypercytokinemia, Lung Fibrosis

Keywords

COVID-19, Critical illness, Hypercytokinemia, Exosomes, Mesenchymal stem cells, Tissue reconstitution, Immune modulation, Sepsis

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.

Interventions

BIOLOGICALApplication 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Germany

Contacts

Primary ContactManfred Weiss, MD

manfred.weiss@uniklinik-ulm.de+49(0)731500

Backup ContactMarion Schneider, PhD

marion.schneider@uni-ulm.de+49(0)731500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026