Immune Modulation by Exosomes in COVID-19 (IMECOV19)

January 16, 2024 updated by: Manfred Weiss, University of Ulm

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Ulm, Germany, 89070
        • Recruiting
        • Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine
        • Contact:
        • Principal Investigator:
          • Manfred Weiss, MD
        • Principal Investigator:
          • Marion Schneider, PhD
        • Sub-Investigator:
          • Bettina Jungwirth, MD
        • Sub-Investigator:
          • Karl Traeger, MD
        • Principal Investigator:
          • Benedikt Nussbaum, MD
        • Contact:
        • Sub-Investigator:
          • Eberhard Barth, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Critically ill COVID-19 patients, COVID-19 WHO severity degree >= 4, ARDS (WHO Definition 13 March 2020)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune phenotyping
Time Frame: 1 year
Immune phenotypes related to type I interferon signaling
1 year
Genetic predisposition to hyperinflammation
Time Frame: 1 year
Determination of functional single nucleotide polymorphisms of inflammatory genes and receptors
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lung fibrosis in COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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