Table 2.
Recent observational and clinical trials of extracellular vesicles in inflammatory diseases
| Trial identifier (ClinicalTrials.gov) | Trial phase | Condition | Trial purpose or intervention | Start date | Status |
|---|---|---|---|---|---|
| NCT05191381 | Observational | Critically ill patients with COVID-19, having hypercytokinaemia and lung fibrosis | To characterize the anti-inflammatory and immune modulatory function of MSC-derived exosomes in a whole blood assay | 22 December, 2021 | Recruiting (estimated completion 31 December, 2022) |
| NCT04979767 | Observational | Bacterial sepsis | To define immune pathways and identify clinically useful biomarkers | 15 April, 2021 | Recruiting (estimated completion 30 June, 2022) |
| NCT04850469 | Observational | Severe infection in children | To evaluate the application of MSC-derived exosomes | 1 January, 2022 | Not yet recruiting (estimated completion 31 December, 2024) |
| NCT05072951 | Observational | Kidney transplant | To define a urine biomarker for transplant rejection | October 2021 | Not yet recruiting (estimated completion October 2025) |
| NCT04653610 | Observational | HIV-1 infection | To determine the expression profile and content of EVs before and after treatment initiation | 27 January, 2021 | Recruiting (estimated completion January 2025) |
| NCT04852653 | Observational | Rectal cancer | To detect tumour cell-derived EVs in liquid biopsy | May 2021 | Not yet recruiting (estimated completion November 2023) |
| NCT05061212 | Observational | Acute respiratory distress syndrome | To determine the role of EVs containing mitochondrial DNA | 1 October, 2021 | Not yet recruiting (estimated completion 31 December, 2022) |
| NCT04892433 | Observational | CAR T cell therapy | To study microRNAs derived from EVs and correlate with clinical outcome | 14 May, 2021 | Recruiting (estimated completion April 2026) |
| NCT05215288 | Early phase I | Abdominal solid organ transplant rejection | Treatment with bone marrow MSC-derived EVs | June 2022 | Not yet recruiting (estimated completion December 2022) |
| NCT04664738 | Phase I | Skin graft | Treatment with platelet-derived EVs | 16 March, 2021 | Enrolling by invitation (estimated completion December 2022) |
| NCT05116761 | Phase I/II | Post-acute COVID-19 or chronic post-COVID-19 syndrome | Treatment with bone marrow MSC-derived EVs | March 2022 | Not yet recruiting (estimated completion August 2022) |
| NCT04798716 | Phase I/II | Pneumonia or acute respiratory distress syndrome caused by COVID-19 | Treatment with MSC-derived exosomes delivered intravenously | Estimated September 2021 | Not yet recruiting (estimated completion 2021) |
| NCT05127122 | Phase I/II | Acute respiratory distress syndrome | Treatment with bone marrow MSC-derived EVs delivered intravenously | March 2022 | Not yet recruiting (estimated completion August 2022) |
| NCT04969172 | Phase II | COVID-19 | Treatment with exosomes overexpressing CD24 | 11 July, 2021 | Active, not yet recruiting (estimated completion 11 July, 2022) |
| NCT04902183 | Phase II | COVID-19 | Treatment with exosomes overexpressing CD24 | 9 June, 2021 | Recruiting (estimated completion 1 September, 2021) |
| NCT05125562 | Phase II | COVID-19 | Treatment with bone marrow MSC-derived EVs | 7 February, 2022 | Not yet recruiting (estimated completion 7 December, 2022) |
| NCT05216562 | Phase II/III | SARS-CoV-2 infection | Treatment with MSC-derived exosomes delivered intravenously | 1 July, 2021 | Recruiting (estimated completion 30 December, 2022) |
| NCT04761562 | Phase II/III | Chronic otitis media treated with tympanic membrane perforation | Treatment with platelet-rich and EV-rich plasma | 14 February, 2021 | Recruiting (estimated completion 30 September, 2023) |
Recent clinical trials (starting in 2021 and 2022) focusing on EVs in inflammatory diseases were extracted from ClinicalTrials.gov using the search terms “exosomes” and “extracellular vesicles”, and filtered for diseases and conditions with an immune-mediated, inflammatory background. CAR, chimeric antigen receptor; EV, extracellular vesicle; MSC, mesenchymal stem cell.