IMECOV19: Immune Modulation by Exosomes in COVID-19

Sponsor
University of Ulm (Other)
Overall Status
Recruiting
CT.gov ID
NCT05191381
Collaborator
(none)
40
1
12.3
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Application of exosomes in a whole blood assay

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19
Actual Study Start Date :
Dec 22, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Immune phenotyping [1 year]

    Immune phenotypes related to type I interferon signaling

  2. Genetic predisposition to hyperinflammation [1 year]

    Determination of functional single nucleotide polymorphisms of inflammatory genes and receptors

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine Ulm Germany 89070

Sponsors and Collaborators

  • University of Ulm

Investigators

  • Principal Investigator: Manfred Weiss, MD, Clinic of Anaesthesiology and Intensive Care Medicine
  • Principal Investigator: Marion Schneider, PhD, Clinic of Anaesthesiology and Intensive Care Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Manfred Weiss, Professor, MD, MBA, Clinical Professor, University of Ulm
ClinicalTrials.gov Identifier:
NCT05191381
Other Study ID Numbers:
  • Lung fibrosis in COVID19
First Posted:
Jan 13, 2022
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Manfred Weiss, Professor, MD, MBA, Clinical Professor, University of Ulm
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2022