Table 12. Highlighted Exosome Diagnostic Clinical Trialsa.
| Companies/medical centers/universities (location) | Exosome (disease target) | Disease diagnosed | Clinical trial number | Clinical trial status (date initiated) | Summary |
|---|---|---|---|---|---|
| University of Alabama at Birmingham (USA) | blood- or urine-derived exosomes (LRRK2) | Parkinson’s disease | NCT04350177 | completed (2013) | Researchers used this study to determine exosome biomarkers for Parkinson’s disease and to determine if LRKK2 expression within exosomes from LRRK2 kinase inhibitor sunitinub treated patients decreased after treatment. They hope to use this information to build an assay for on-target effects for future LRRK2 inhibitor clinical trials.511 |
| Boston University (USA) | plasma-derived exosome (tau) | chronic traumatic encephalopathy | NCT02798185 | active (2016) | Boston University researchers collaborated with Exosome Sciences and Aethlon Medical for the DETECT CTE research project, which aims to validate exosomal tau as a non-invasive CTE biomarker. Preliminary findings look promising that plasma exosomal tau may be an accurate, non-invasive biomarker for CTE.328 Researchers are using this clinical trial as an advancement to the previous study with the goal of diagnosing CTE during life for the prevention and treatment of the disease. |
| Exosome Diagnostics (USA) | urine-derived exosome (ERG, PCA3, and SPDEF) | prostate cancer | NCT02702856 | completed (2016) | Exosome Diagnostics developed the ExoDx test that utilizes circulating cancer exosomes from urine-derived exosomes and is commercially available. The ExoDx test was granted FDA Breakthrough Device Designation in 2019.512 They also have current clinical trials for the use of exosomes in diagnosis of non-small-cell lung cancer513 and kidney transplant rejection.514 Preliminary data from their breast cancer trial reveals specific gene signatures could be isolated from plasma-derived exosomes,515 and their kidney transplant trial showed the discovery of two separate gene signatures for the monitoring of kidney transplant rejections.516 They have also had success preclinically with identifying plasma biomarkers for glioblastoma517 and a saliva exosomal RNA signature for Sjogren’s syndrome.518 |
| miR Scientific (USA) | urine-derived exosome (442 sncRNA) | bladder cancer | NCT04155359 | recruiting (2019) | miR Scientific developed the miR Sentinel test currently commercially available for prostate cancer detection with extracted sncRNA in urine-derived exosomes.519 They are investigating through this clinical trial if there is evidence that they can also diagnose bladder cancer with the miR Sentinel test. The miR Sentinel test received FDA Breakthrough Device Designation in 2020.520 |
| University of Utah Center for Clinical and Translational Science (USA) | urine-derived exosomes (sodium transporters) | heart failure with preserved ejection fraction (HFpEF) | NCT03837470 | completed (2019) | This trial examines sodium transporters in the exosomes from patients with HFpEF for characterization to aid in diagnosis and treatment of these patients.521 |
| Aarhus University Hospital (Denmark) | plasma-derived exosomes | acute ischemic stroke | NCT04266639 | completed (2020) | This trial was performed to determine if exosome isolation with characterization of the nucleic acid (DNA and RNA, including miRNA) content will show any decrease in stroke complications and any advantage of remote ischemic conditioning.522 |
| Lithuanian University of Health Sciences (Lithuania) | eosinophil-derived exosome | asthma | NCT04542902 | recruiting (2020) | This clinical trial’s investigation of ncRNA in eosinophil-derived exosomes will provide insights on eosinophils subtypes in airway remodeling. ncRNAs are key regulators for gene transcription, and researchers predict that altered blood levels of ncRNAs could be a diagnostic biomarker in asthma.523 |
| Peking Union Medical College Hospital (China) | blood and bronchoalveolar lavage fluid (BALF)-derived exosomes | ARDS | NCT05451342 | recruiting (2022) | This clinical trial will characterize exosomes from blood and BALF with transcriptome and metabolomic analysis to aid in the diagnosis of ARDS.524 |
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Details obtained from https://clinicaltrials.gov/.