Using exosomes to modulate the immune response in critically ill COVID-19 patients
Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19
This study is testing whether exosomes from stem cells can help improve the immune response and reduce inflammation in critically ill COVID-19 patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Ulm Academic / other |
| Locations | 1 site (Ulm) |
| Trial ID | NCT05191381 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the immune-modulating effects of exosomes derived from mesenchymal stem cells in critically ill patients suffering from COVID-19. By stimulating whole blood samples from these patients, the study aims to analyze immune phenotypes, cytokine release, and mRNA expression patterns. The goal is to understand how these exosomes can potentially reduce inflammation and support anti-fibrotic pathways in patients experiencing severe lung dysfunction due to COVID-19.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill COVID-19 patients with lung dysfunction and a WHO severity degree of 4 or higher.
Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to new therapeutic strategies for managing severe COVID-19 cases and improving patient outcomes.
How similar studies have performed: While the use of exosomes in immune modulation is a growing field, this specific approach in critically ill COVID-19 patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ulm
- Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Manfred Weiss, MD — Clinic of Anaesthesiology and Intensive Care Medicine
- Study coordinator: Manfred Weiss, MD
- Email: manfred.weiss@uniklinik-ulm.de
- Phone: +49(0)731500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.