From: Therapeutic role of mesenchymal stem cell-derived exosomes in respiratory disease
No | Title and sponsor | Trial ID | Location | Design | Primary outcome | Recruitment status | Phase |
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1. | The use of exosomes for the treatment of acute respiratory distress syndrome or novel coronavirus pneumonia caused by COVID-19 (ARDOXSO) Sponsor: AVEM HealthCare | NCT04798716 | United States, California | Open label, interventional, mesenchymal stem cell exosomes for the treatment of COVID-19 positive patients with acute respiratory distress syndrome and/or novel coronavirus pneumonia N:55 | Measure and report the number of participants with treatment-related-adverse events Tabulate and report the number of IMV days for patients receiving ARDOXSO™ perinatal MSC-derived exosome therapy | Not yet recruiting July 21, 2021 | Phase 1 Phase 2 |
2. | Safety and efficiency of method of exosome inhalation in COVID-19 associated pneumonia (COVID-19EXO2) Sponsor: Olga Tyumina | NCT04602442 | Russian, Samara | Randomized, interventional, the extended protocol of evaluation of safety and efficiency of method of exosome inhalation in COVID-19 associated two-sided pneumonia N: 90 | Number of participants with non-serious and serious adverse events during trial Number of participants with non-serious and serious adverse during inhalation procedure | Enrolling by invitation October 26, 2020 | Phase 2 |
3. | Evaluation of safety and efficiency of method of exosome inhalation in SARS-CoV-2 associated pneumonia. (COVID-19EXO) Sponsor: State-Financed Health Facility “Samara Regional Medical Center Dinasty” | NCT04491240 | Russian, Samara | Randomized, interventional, the protocol of evaluation of safety and efficiency of method of exosome inhalation in SARS-CoV-2 associated two-sided pneumonia N: 30 | Number of participants with non-serious and serious adverse events during trial Number of participants with non-serious and serious adverse during inhalation procedure | Completed November 4, 2020 | Phase 1 Phase 2 |
4. | A safety study of IV stem cell-derived extracellular vesicles (UNEX-42) in preterm neonates at high risk for BPD Sponsor: United Therapeutics | NCT03857841 | United States, Colorado, Massachusetts, Mississippi, Missouri | Randomized, interventional, a safety study of intravenous infusion of bone marrow mesenchymal stem cell-derived extracellular vesicles (UNEX-42) in preterm neonates at high risk for bronchopulmonary dysplasia N: 3 | Number of subjects with treatment-emergent adverse events during the post-treatment phase | Terminated October 12, 2021 | Phase 1 |
5. | A clinical study of mesenchymal stem cell exosomes nebulizer for the treatment of ARDS Sponsor: Ruijin Hospital | NCT04602104 | China, Shanghai | Randomized, double-blinded, controlled clinical study of allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) nebulized inhalation in the treatment of acute respiratory distress syndrome N:169 | Incidence of adverse reaction Time to clinical improvement 28-day mortality | Recruiting November 2, 2021 | Phase 1 Phase 2 |
6. | A tolerance clinical study on aerosol inhalation of mesenchymal stem cells exosomes in healthy volunteers Sponsor: Ruijin Hospital | NCT04313647 | China, Shanghai | Open label, non randomized, interventional, a tolerance clinical study on aerosol inhalation of mesenchymal stem cells exosomes in healthy volunteers N: 24 | Number of Participants With Adverse Reaction (AE) and severe adverse reaction (SAE) | Completed August 4, 2021 | Phase 1 |
7. | Omics sequencing of exosomes in body fluids of patients with acute lung injury Sponsor: Nanfang Hospital of Southern Medical University | NCT05058768 | China, Guangdong | Observational, case–control, exosomes in urine, blood, and alveolar lavage fluid from patients with acute respiratory distress syndrome (ADRS) were sequenced by omics N:180 | Compare the omics differences of blood samples between the experimental and control groups Compare the omics differences of urine samples between the experimental and control groups | Recruiting September 28, 2021 | Case–Control |
8. | Exosomes derived from placental mesenchymal stem cells as treatment for severe COVID-19: Phase 1 and 2 clinical trials Sponsor: Omid Cell and Tissue center | IRCT20200413047063N2 | Tehran, Iran | Participants were randomly divided into two equal groups using a randomized double AB blocking method based on a random number table. Patients allocated randomly to two groups: (1) Intervention 1, Patients will receive Six doses of Exosomes. (2) Control, Patients will receive conventional therapy N:50 | Adverse events assessment | Recruiting July 8, 2021 | Phase 1 Phase 2 |
9. | Molecular profiling of exosomes in tumor-draining vein of early-staged lung cancer (ExOnSite-Pro) Sponsor: University Hospital, Limoges | NCT04939324 | France, Limoges | Open label, single group assignment, Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce N:30 | Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion | Recruiting November 11, 2021 | Not applicable |
10. | A pilot clinical study on inhalation of mesenchymal stem cells exosomes treating severe novel coronavirus pneumonia Sponsor: Ruijin Hospital | NCT04276987 | China, Shanghai | Open label, single group assignment, 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 N:24 | Adverse reaction (AE) and severe adverse reaction (SAE) Time to clinical improvement (TTIC) | Completed September 7, 2020 | Phase 1 |
11. | Extracellular vesicle infusion treatment for COVID-19 Associated ARDS (EXIT-COVID19) Sponsor: Direct Biologics, LLC | NCT04493242 | United States, Alabama, California, Pennsylvania, Texas | Randomized, double-blinded, bone marrow mesenchymal stem cell derived extracellular vesicles infusion treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): a phase II clinical trial N: 120 | 7 day change in partial pressure of arterial oxygen to fraction of inspired oxygen ratio | Completed December 6, 2021 | Phase 2 |
12. | Safety and efficacy of exosomes overexpressing CD24 in two doses for patients with moderate or severe COVID-19 Sponsor: Athens Medical Society | NCT04902183 | Greece, Athens, Attica | Randomized, single, a Phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 in 10^9 dose versus 10^10 dose, for the prevention of clinical deterioration in patients with moderate or severe COVID-19 N:90 | Collection of serious adverse events Proportion of patients related with Respiratory rate and SpO2 saturation | Recruiting June 15, 2021 | Phase 2 |