Table 1.
List of clinical trials* on the use of stem cell-derived exosomes in COVID-19 management
| Reference | Official title | Sponsor | Status |
|---|---|---|---|
| NCT04657458 | Bone marrow mesenchymal stem cell-derived extracellular vesicles infusion treatment: expanded access protocol for patients with COVID-19-associated ARDS who do not qualify for Phase II randomized control trial | Direct Biologics, LLC, USA | Completed (results available) |
| NCT04491240 | Evaluation of safety and efficiency of method of exosome inhalation in SARS-CoV-2-associated pneumonia | State Financed Health Facility, Russia | Completed (results available) |
| NCT04276987 | A pilot clinical study on aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells in the treatment of severe patients with novel coronavirus pneumonia | Ruijin Hospital, China | Completed (results not available) |
| NCT04493242 | Bone marrow mesenchymal stem cell-derived extracellular vesicles infusion treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): a Phase II clinical trial | Direct Biologics, LLC, United States | Completed (results not available) |
| IRCT20130812014333N164 | Investigation of the effects of the exosomes derived from placental mesenchymal stem cells on the oxygen saturation and biological markers of patients with COVID-19 | Kermanshah University of Medical Sciences, Iran | Ongoing |
| ISRCTN33578935 | Rationale and investigational study for the treatment of COVID-19 with severe viral pneumonia with isolated, placental, mesenchymal stem cell exosomes | Kimera Labs, United States | Ongoing |
| NCT04902183 | A Phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 in 109 dose versus 1010 dose, for the prevention of clinical deterioration in patients with moderate or severe COVID-19 | Athens Medical Society, Greece | Recruiting |
| IRCT20190101042197N2 | Evaluation of the safety and efficiency of mesenchymal stem cell-derived exosomes in patients with ARDS of COVID-19; An interventional randomized double-blind controlled clinical trial: phase I and II | Tarmim Ava Baran Knowledge Based Company, Iran | Recruiting |
| IRCT20201202049568N3 | Evaluation of the safety and efficiency of human umbilical cord derived mesenchymal stem cell exosomes in patients with ARDS of COVID-19; an interventional randomized double-blind controlled clinical trial: phase I and II | Tarmim Ava Baran Knowledge Based Company, Iran | Recruiting |
| IRCT20200413047063N2 | Exosomes derived from placental mesenchymal stem cells as treatment for severe COVID-19: Phase 1 & 2 clinical trials | Omid Cell and Tissue center, Iran | Recruiting |
| NCT04747574 | A Phase I feasibility study to evaluate the safety of CD24-exosomes in patients with moderate/severe COVID-19 infection | Tel-Aviv Sourasky Medical Center, Israel | Recruiting |
| IRCT20200510047385N1 | Effect of stromal vascular fraction (SVF), blood and condition medium derived exosomes on treatment of covid-19 patients with acute respiratory distress syndrome (ARDS)/clinical Trial | Tabriz University of Medical Sciences, Iran | Recruiting |
| NCT04602442 | The extended protocol of evaluation of safety and efficiency of method of exosome inhalation in COVID-19-associated two-sided pneumonia | Olga Tyumina, Russia | Recruiting |
| NCT05191381 | Immune modulation by exosomes in COVID-19 (IMECOV19) | University of Ulm, Germany | Recruiting |
| NCT04798716 | Mesenchymal stem cell exosomes for the treatment of COVID-19-positive patients with acute respiratory distress syndrome and/or novel coronavirus pneumonia | AVEM HealthCare, United States | Not yet recruiting |
| NCT04389385 | Aerosol inhalation of the exosomes derived from allogenic COVID-19 T cell in the treatment of early stage novel coronavirus pneumonia | TC Erciyes University, Turkey | Not yet recruiting |
| ChiCTR2000030484 | HUMSCs and exosomes treating patients with lung injury following novel coronavirus pneumonia (COVID-19) | Hubei Shiyan Taihe hospital, China | Not yet recruiting |
| ChiCTR2000030261 | A study for the key technology of mesenchymal stem cells exosomes atomization in the treatment of novel coronavirus pneumonia (COVID-19) | Wuxi Fifth People's Hospital, China | Not yet recruiting |
| NCT04969172 | A Phase II randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration in patients with moderate or severe COVID-19 infection | Eli Sprecher, MD, United States | Not yet recruiting |
*Obtained from trialsearch.who.int, clinicaltrials.gov and clinicaltrialsregister.eu using “extracellular vesicles” or “exosomes” as search strings, with results restricted to COVID-19