Table 1.
Clinical trials that evaluate the introduction of extracellular vesicles (EVs) in circulation.
| Condition or Disease |
Phase, Participants |
EV Source | EV Dose | Administration | EV Loading or Modifications |
Status or Results | Reference |
|---|---|---|---|---|---|---|---|
| Metastatic melanoma |
Phase I, n = 15 |
Autologous monocyte- derived dendritic cells |
0.13–0.4 × 1014 MHC class II molecules, 4 injections (weekly) |
Subcutaneous and intradermal |
Pulsed with MAGE-3 peptides |
No grade II toxicity; 1 partial, 1 minor, 2 stable and 1 mixed response |
[178] |
| Non-small cell lung cancer | Phase I, n = 9 |
Autologous monocyte- derived dendritic cells |
0.13 × 1014 MHC-II molecules, 4 injections (weekly) |
Subcutaneous and intradermal |
Pulsed with MAGE-A3, -A4, -A10, and -3DPO4 peptides |
Well tolerated; disease stabilization in some patients |
[179] |
| Non-small cell lung cancer | Phase II, n = 22 |
Autologous monocyte-derived dendritic cells, induced by INF-γ | 8.5 × 1011–1 × 1013 MHC-II molecules, 4 injections (weekly) |
Intradermal | Pulsed with MAGE-A1, -A3, NY-ESO-1, Melan-A/MART1, MAGE-A3-DP04, EBV peptides |
1 patient grade 3 hepatotoxicity; stabilization in 32% patients, endpoint not reached (50%) |
NCT01159288 [180] |
| Colorectal cancer |
Phase I, n = 40 |
Autologous ascites (some patients in combination with GM-CSF 1) | 100–500 μg (protein quantification), 4 injections (weekly) |
Subcutaneous | Not modified | Well tolerated; 1 stable disease and 1 minor response (both with EVs+GM-CSF) | [181] |
| Chronic kidney disease |
Phase II/III, n = 40 |
Allogeneic umbilical cord mesenchymal stem cells |
100 μg/kg/dose (protein quantification), 2 injections (one week apart) |
Intravenous and intra-arterial |
Not modified | Well tolerated; improved overall kidney function |
[182] |
| Cutaneous ulcer (Wound healing) |
Early phase I, n = 5 | Autologous, derived from plasma |
Dose not reported, 28 doses (daily) |
“Applied to the participants’ ulcers” |
Not modified | Enrolling by invitation |
NCT02565264 |
| Venous ulcer (Wound healing) |
Phase not applicable, n = 10 |
Autologous, derived from serum |
Dose not reported, 3 injections (weekly) |
Peri-wound injection |
Not modified | Recruiting | NCT04652531 |
| Acute myocardial infarction |
Phase I, n = 18 |
Allogeneic platelets |
5%, 10% or 20% PEP (Purified Exosome ProductTM), single dose |
Intracoronary | Not reported | Not yet recruiting | NCT04327635 |
| PTN 2 at high risk for bronchopulmonary dysplasia | Phase I, n = 18 |
Bone marrow mesenchymal stem cell |
20–200 pmol phospholipid/kg |
Intravenous | Not reported | Active, not recruiting |
NCT03857841 |
| ARDS 3 in patients with severe COVID-19 |
Phase II, n = 60 |
Allogeneic bone marrow mesenchymal stem cells |
ExoFlo, dose not reported | Intravenous | Not reported | Not yet recruiting |
NCT04493242 See also NCT04657458 and [183] |
| Periodontitis | Early phase I, n = 10 | Autologous adipose-derived stem cells |
Dose not reported | Injected into periodontal pockets |
Not reported | Recruiting | NCT04270006 |
| Metastatic pancreatic cancer with KrasG12D mutation |
Phase I, n = 28 |
Mesenchymal stemcells |
Dose-escalation study, injection on days 1, 4, and 10 (up to max. 6 courses) |
Intravenous | Loaded with KrasG12D siRNA | Recruiting |
NCT03608631 See also [174] |
1 GM-CSF: Granulocyte–macrophage colony-stimulating factor; 2 PTN: Preterm neonates; 3 ARDS: Acute respiratory distress syndrome.