Table 11. Highlighted Exosome Therapeutic Clinical Trialsa.
| Companies/medical centers/universities (location) | Exosome | Disease treated | Clinical trial number | Clinical trial stage or status (date initiated) | Summary |
|---|---|---|---|---|---|
| M.D. Anderson Cancer Center (USA) | MSC-derived exosomes with KrasG12D siRNA (iExosomes) | metastatic pancreatic cancer with KrasG12D mutation | NCT03608631 | phase I (2018) | This study researches the optimal dose and the drug toxicity of using iExosomes in treating metastatic pancreatic cancer patients.491 |
| Neurological Associates of West Los Angeles (USA) | exosomes | cranial facial neuralgia | NCT04202783 | suspended (due to COVID-19 pandemic) (2019) | This study will evaluate the safety and efficacy of exosome treatment in patients with craniofacial neuralgia.492 |
| Organicell Regenerative Medicine (USA) | amniotic-fluid-derived exosomes/Zofin (organicell flow) | mild/moderate COVID-19 | NCT04657406 | expanded access status available (2020) | The therapeutic Zofin is currently undergoing clinical trials for COVID-19, COPD, and osteoarthritis.493 |
| Direct Biologics (USA) | bone marrow MSC-derived exosomes/DB-001/ExoFlo | COVID-19 ARDS | NCT04657458 | expanded access status available (2020) | Their therapeutic ExoFlo is currently undergoing clinical trials for COVID-19-associated moderate to severe ARDS, ulcerative colitis, Crohn’s disease/irritable bowel syndrome, and organ transplant rejection.494 |
| Rion (USA) | purified exosome product (PEP) | skin graft | NCT04664738 | phase I (2020) | Rion is researching with this clinical trial the application of their PEP therapeutic (a leukocyte depleted blood preparation derived from apheresed platelets) in patients with a skin graft for wounds to determine if it offers improvement in healing properties over the standard wound dressing treatment.495 |
| Ruijin Hospital (China) | adipose mesenchymal stem-cell-derived exosomes (MSCs-Exos) | Alzheimer’s-disease-induced dementia | NCT04388982 | phase I/II (2020) | The purpose of this study is to explore the safety and efficacy of MSCs-Exos in the treatment of mild to moderate dementia due to Alzheimer’s disease.496 |
| Rion (USA) | purified exosome product (PEP) | acute myocardial infarction | NCT04327635 | phase II (2020) | Rion’s PEP exosome therapeutic is currently in preclinical and clinical studies for multiple indications497 including acute myocardial infarction, wound healing,498 pelvic floor disorders,499 hair loss treatment, and degenerative joint disease500,501 with many encouraging results. |
| University of Louisville (USA) | ginger exosomes with/without curcumin | irritable bowel disease | NCT04879810 | recruiting (2021) | The purpose of this clinical trial is to test if edible ginger exosomes will have clinically relevant anti-inflammatory action on the gut lining of patients with inflammable bowel disease.437 The University of Louisville also has an active clinical trial exploring edible plant exosomes conjugated to curcumin for the treatment of colon cancer.502 They also conducted a completed clinical trial researching grape exosomes dosed as grape powder to reduce the incidence of oral mucositis during radiation and chemotherapy cancer treatments.439 |
| OBCTCD24 (Israel) | exosomes overexpressing CD24/CovenD24/EXO-CD24 | moderate or severe COVID-19 | NCT04902183 | phase I (2021) | OBCTCD24 has their product EXO-CD24/CovenD24 in one other clinical trial. CovenD24 is an exosome overexpressing CD24 administered through inhalation dosing for the treatment of moderate or severe COVID-19.298 |
| Aegle Therapeutics (USA) | bone marrow MSC-derived exosomes/AGLE-102 | burns | NCT05078385 | phase I (2021) | Preclinical data reveals that exosomes isolated by Aegle accelerated healing, minimized scars, and promoted blood vessel and nerve regeneration, as well as hair follicle growth.503 In addition to burns, AGLE-102 is also in a clinical trial for the treatment of dystrophic epidermolysis bullosa, a group of rare genetic disorders that presents with blistering or erosion of the skin in response to little or no trauma.504 |
| Maimónides Biomedical Research Institute of Córdoba (Spain) | MSC-derived exosomes | wound healing/skin ulcers in diabetic patients | NCT05243368 | not yet recruiting (2022) | The focus of this clinical trial is to develop a therapeutic process to accelerate the healing of diabetic chronic skin ulcers, based on nutritional intervention and the application of MSC-derived exosomes to the wound, to improve skin regeneration.505 |
| Codiak BioSciences (USA) | exosomes loaded with a synthetic lipid-tagged oligonucleotide/CDK-004/exoASO-STAT6 | advanced hepatocellular carcinoma (HCC)/liver metastasis | NCT05375604 | phase I (2022) | In addition to HCC,506 Codiak also has clinical trials for treatment of cutaneous T-cell lymphoma, solid tumors, and non-small-cell lung cancer. They have also developed an exosome-based vaccine on their engEx platform for the treatment of beta coronavirus, Epstein–Barr virus, and HIV.507 Recent preclinical data resulted in positive results for their pan-beta coronavirus vaccine, ecoVACC showing the probable protection from additional beta-coronaviruses and emerging variants.508 |
| Vitti Laboratories (USA) | umbilical-cord-derived exosomes/EV-Pure in combination with Wharton’s jelly MSCs (WJ-Pure) | moderate to severe ARDS associated with COVID-19 | NCT05387278 | phase I (2022) | While Vitti Laboratories has two current clinical trials,509 they have many more disease indications in their pipeline for their EV-Pure exosomal product along with exosomal-based topical and serum applications for wound healing and age-related macular degeneration, respectively. Their EV-Pure product is currently researched preclinically for treatment of COPD, osteoarthritis, traumatic brain injury, Crohn’s disease, polycystic ovarian syndrome, and Alzheimer’s disease.510 |
a
Details obtained from https://clinicaltrials.gov/.