Clinical trials of exosomes for malignant and acute conditions
| Disease | Clinical trial ID | Study title | Phase | No. of patients | Study type | Source of MSC | Route of administration | Dose |
|---|---|---|---|---|---|---|---|---|
| OA | NCT05060107 | Intra-articular injection of MSC-derived exosomes in knee OA | 1 | 10 | Open label | N/A | IA | Single dose (3∼5×1011 particles/dose) |
| Macular degeneration | NCT03437759 | MSC-Exos promote healing of MHs | 1 | N/A | Randomized | Umbilical cord tissue | Local | 50 or 20 μg MSC-Exos |
| Type I diabetes mellitus | NCT02138331 | Effect of microvesicles and exosomes therapy onβ-cell mass in type I diabetesmellitus (T1D) | 02-Mar | N/A | Interventional open-label | Umbilical cord blood | IV | Two doses (one week apart) of exosomes produced from 1.22∼1.51×106 MSCs/kg |
| Ischemic stroke | NCT03384433 | Allogeneic mesenchymal stem cell-derived exosome inpatients with acute ischemic stroke | 01-Feb | 5 | Randomized, single-blinded, placebo-controlled | Bone marrow | Intraparenchymal | Single dose of (200 mg MSC-Exos) |
| Dry eye | NCT04213248 | Effect of UC-MSC-Exos on dry eye in patients With cGVHD | 01-Feb | 27 | Single group | Umbilical cord | Artificial tears | UC-MSC-Exos 10 μg/drop, 4 times a day for 14 days |
| Alzheimer’s disease | NCT04388982 | The safety and the efficacy evaluation of allogeneic adipose MSC-Exos in patients with Alzheimer’s disease | 01-Feb | 9 | Non-randomized | Adipose tissue | Nasal drip | 5/10/20 μg ASC-Exos weekly twice |
| ARDS | NCT04602104 | A clinicalstudy of mesenchymal stem cell exosomes nebulizer for the treatment of ARDS | 01-Feb | 169 | Randomized, double-blinded, controlled | N/A | Inhalation | 2.0×108 exosomes, 8.0×108 vesicles, 16.0×108 exosomes (every day in a week) |
| Pulmonary infection | NCT04544215 | A clinical study of mesenchymal progenitor cell exosomes nebulizer for the treatment of pulmonary infection | 01-Feb | 60 | Randomized, double-blinded, controlled | Adipose tissue | Inhalation | 8.0×108 exosomes/3 ml, 16.0×108 exosomes/3 ml (every day in a week) |
| Dystrophic epidermolysis bullosa | NCT04173650 | MSC-EVs in dystrophic epidermolysis bullosa | N/A | 10 | Single group | Bone marrow | Local | N/A |
| Multiple organ dysfunction syndrome | NCT04356300 | Multiple organ dysfunction syndrome after surgical repair of acute type A aortic dissection | N/A | 60 | Interventional | N/A | IV | 150 mg once a day (14 times) |
| Periodontitis | NCT04270006 | Evaluation of adipose derived stem cells exo in treatment of periodontitis (exosomes) | 1 | 10 | Open label | Adipose tissue | Local | N/A |
| Metastatic pancreas cancer | NCT03608631 | iExosomes in treating participants with metastatic pancreas cancer with KrasG12D mutation | 1 | 28 | Open label | N/A | IV | N/A |
| COVID-19 | NCT04276987 | A pilot clinical study on inhalation of mesenchymal stem cells exosomes treating severe novel coronavirus pneumonia | 1 | 24 | Pilot/open-label | Adipose tissue | Inhalation | 5 times of MSC-Exos (2×108 nanovesicles/ 3 ml at Day 1∼5) |
| SARS-CoV-2 | NCT04491240 | SARS-CoV-2 associated pneumonia | 1 | 30 | Interventional | N/A | Inhalation | Twice a day for 10 days inhalation of 3 ml (0.5∼2×1010 of nanoparticles) |
| Normal and colon cancer tissue | NCT01294072 | Phase I clinical trial investigating the ability of plant exosomes to deliver curcumin to normal and malignant colon tissue | 1 | 35 | Interventional | Plant (grape) | Curcumin cargo | Curcumin combined with plant exosomes (every day in a week) |
MSC: mesenchymal stem cell, ARDS: acute respiratory distress syndrome, COVID-19: coronavirus disease 2019, SARS-CoV-2: severe acute respiratory syndrome coronavirus 2, OA: osteoarthritis, N/A: not available, IA: intraarticular, MSC-Exos: MSC-derived exosomes, MHs: medication history, IV: intravenous, UC: ulcerative colitis, cGVHD: chronic graft-versus-host disease, ASC: adipose stem cell, EVs: extracellular vesicles.