Immune Modulation by Exosomes in COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Application of exosomes in a whole blood assay.
- Who it may be relevant to
- Registry conditions: COVID-19, Critical Illness, Hypercytokinemia, Lung Fibrosis. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19
Overview
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
- 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.
Primary outcome measures
- Cytokine profile in supernatants [Time frame: 24 hours, 1 year]
Secondary outcome measures (2)
- Immune phenotyping [Time frame: 1 year]
- Genetic predisposition to hyperinflammation [Time frame: 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Ulm University Hospital, Clinic of Anesthesiology and Intensive Care Medicine — Ulm
Publications
- Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2. PMID 28466096
- Di Rocco G, Baldari S, Toietta G. Towards Therapeutic Delivery of Extracellular Vesicles: Strategies for In Vivo Tracking and Biodistribution Analysis. Stem Cells Int. 2016;2016:5029619. doi: 10.1155/2016/5029619. Epub 2016 Nov 23. PMID 27994623
- Geistlinger J, Du W, Groll J, Liu F, Hoegel J, Foehr KJ, Pasquarelli A, Schneider EM. P2RX7 genotype association in severe sepsis identified by a novel Multi-Individual Array for rapid screening and replication of risk SNPs. Clin Chim Acta. 2012 Jan 18;413(1-2):39-47. doi: 10.1016/j.cca.2011.05.023. Epub 2011 May 25. PMID 21640086
- Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, Damoraki G, Gkavogianni T, Adami ME, Katsaounou P, Ntaganou M, Kyriakopoulou M, Dimopoulos G, Koutsodimitropoulos I, Velissaris D, Koufargyris P, Karageorgos A, Katrini K, Lekakis V, Lupse M, Kotsaki A, Renieris G, Theodoulou D, Panou V, Koukaki E, Koulouris N, Gogos C, Koutsoukou A. Complex Immune Dysregulati PMID 32320677
- Gotts JE, Matthay MA. Endogenous and exogenous cell-based pathways for recovery from acute respiratory distress syndrome. Clin Chest Med. 2014 Dec;35(4):797-809. doi: 10.1016/j.ccm.2014.08.015. Epub 2014 Sep 24. PMID 25453426
- Haberle H, Magunia H, Lang P, Gloeckner H, Korner A, Koeppen M, Backchoul T, Malek N, Handgretinger R, Rosenberger P, Mirakaj V. Mesenchymal Stem Cell Therapy for Severe COVID-19 ARDS. J Intensive Care Med. 2021 Jun;36(6):681-688. doi: 10.1177/0885066621997365. Epub 2021 Mar 5. PMID 33663244
- Lai RC, Arslan F, Lee MM, Sze NS, Choo A, Chen TS, Salto-Tellez M, Timmers L, Lee CN, El Oakley RM, Pasterkamp G, de Kleijn DP, Lim SK. Exosome secreted by MSC reduces myocardial ischemia/reperfusion injury. Stem Cell Res. 2010 May;4(3):214-22. doi: 10.1016/j.scr.2009.12.003. Epub 2010 Jan 4. PMID 20138817
- Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVI PMID 32257537
Identifiers
NCT: NCT05191381 · Lung fibrosis in COVID19