Table 1.
Ongoing clinical trials using MSC-EVs.
| Title | Source of EVs | Conditions | Status | Locations | NCT Number |
|---|---|---|---|---|---|
| iExosomes in Treating Participants with Metastatic Pancreas Cancer with KrasG12D Mutation | MSC-derived Exosomes with KRAS G12D siRNA | Pancreatic Adenocarcinoma | Recruiting | United States | NCT03608631 |
| Allogenic Mesenchymal Stem Cell Derived Exosome in Patients with Acute Ischemic Stroke | MSC-derived exosomes enriched by miR-124 | Cerebrovascular Disorders | Recruiting | Iran | NCT03384433 |
| The Effect of Stem Cells and Stem Cell Exosomes on Visual Functions in Patients with Retinitis Pigmentosa | WJ-MSC | Retinitis Pigmentosa | Not yet recruiting | Turkey | NCT05413148 |
| Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula | Placenta-MSC | Fistula Perianal | Recruiting | Iran | NCT05402748 |
| A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia | ASC | Coronavirus | Completed | China | NCT04276987 |
| A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS | MSC | Acute Respiratory Distress Syndrome | Recruiting | China | NCT04602104 |
| A Clinical Study of Mesenchymal Progenitor Cell Exosomes Nebulizer for the Treatment of Pulmonary Infection | ASC | Drug-resistant | Recruiting | China | NCT04544215 |
| A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes in Healthy Volunteers | ASC | Healthy | Completed | China | NCT04313647 |
| Exosome of Mesenchymal Stem Cells for Multiple Organ Dysfuntion Syndrome after Surgical Repair of Acute Type a Aortic Dissection | UC-MSC | Multiple Organ Failure | Not yet recruiting | China | NCT04356300 |
| MSC-Exos Promote Healing of MHs | UC-MSC | Macular Holes | Active, not recruiting | China | NCT03437759 |
| Clinical Efficacy of Exosome in Degenerative Meniscal Injury | SF-MSC | Knee Meniscus Injury | Recruiting | Turkey | NCT05261360 |
| Effect of UMSCs Derived Exosomes on Dry Eye in Patients with cGVHD | UC-MSC | Dry Eye | Recruiting | China | NCT04213248 |
| Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation in Moderate COVID-19 Patients | MSC | SARS-CoV2 Infection | Recruiting | Indonesia | NCT05216562 |
| Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated with the COVID-19 | UC-MSC | COVID-19/Acute Respiratory Distress Syndrome | Recruiting | United States | NCT05387278 |
| Study of MSC-Exo on the Therapy for Intensively Ill Children | MSC | Sepsis/Critical Illness | Not yet recruiting | China | NCT04850469 |
| The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19 | MSC | COVID-19/Acute Respiratory Distress Syndrome | Not yet recruiting | United States | NCT04798716 |
| Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-1) | UC-MSC | Knee Osteoarthritis | Not yet recruiting | Chile | NCT05060107 |
| the Safety and the Efficacy Evaluation of Allogenic Adipose MSC-Exos in Patients with Alzheimer’s Disease | ASC | Alzheimer’s Disease | Recruiting | China | NCT04388982 |
| Effect of Microvesicles and Exosomes Therapy on β-cell Mass in Type I Diabetes Mellitus (T1DM) | UC-MSC | Diabetes Mellitus Type 1 | Unknown status | Egypt | NCT02138331 |
| MSC EVs in Dystrophic Epidermolysis Bullosa | BM-MSC | Dystrophic Epidermolysis Bullosa | Not yet recruiting | Aegle Therapeutics | NCT04173650 |
| Safety and Efficiency of Method of Exosome Inhalation in COVID-19 Associated Pneumonia | MSC | COVID-19/SARS-CoV-2 Pneumonia | Enrolling by invitation | Russian Federation | NCT04602442 |
| Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia. | MSC | COVID-19/SARS-CoV-2 Pneumonia | Completed | Russian Federation | NCT04491240 |
| Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS | BM-MSC | COVID-19/Acute Respiratory Distress Syndrome/Pneumonia | Completed | United States | NCT04493242 |
| Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS | BM-MSC | Acute Respiratory Distress Syndrome | Not yet recruiting | Direct Biologics | NCT05127122 |
| A Global Expanded Access Protocol on Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Infusion Treatment for Patients with COVID-19 Associated ARDS | BM-MSC | COVID-19/Acute Respiratory Distress Syndrome | Available | Direct Biologics | NCT04657458 |
| Safety of Mesenchymal Stem Cell Extracellular Vesicles (BM-MSC-EVs) for the Treatment of Burn Wounds | BM-MSC | Burns | Not yet recruiting | Aegle Therapeutics | NCT05078385 |
| A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn’s Disease | BM-MSC | Crohn’s Disease/Irritable Bowel Disease | Not yet recruiting | Direct Biologics | NCT05130983 |
| Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19: A Phase II Clinical Trial | BM-MSC | COVID-19 | Not yet recruiting | Austin, United States | NCT05125562 |
| ExoFloTM Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome | BM-MSC | COVID-19/Postviral Syndrome/Dyspnea | Not yet recruiting | Direct Biologics | NCT05116761 |
| Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles as Early Goal Directed Therapy for COVID-19 Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS): A Phase III Clinical Trial | BM-MSC | COVID-19/Acute Respiratory Distress Syndrome | Not yet recruiting | Direct Biologics | NCT05354141 |
| A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD | BM-MSC | Bronchopulmonary Dysplasia | Terminated | United States | NCT03857841 |
| Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis | BM-MSC | Ulcerative Colitis | Not yet recruiting | Direct Biologics | NCT05176366 |
| Intermediate Size Expanded Access for the Use of ExoFlo in the Treatment of Abdominal Solid Organ Transplant Patients Who Are at Risk of Worsening Allograft Function with Conventional Immunosuppressive Therapy Alone | BM-MSC | Solid Organ Transplant Rejection | Not yet recruiting | Direct Biologics | NCT05215288 |
MSC: MSC from unknown source; BM-MSC: Bone Marrow-derived MSC; ASC-MSC: Adipose Tissue-derived MSC; UC-MSC: Umbilical Cord-derived MSC; SF-MSC: Synovial Fluid-derived MSC; WJ-MSC: Wharton Jelly-derived MSC.