Table 9.1
Current and past NIH registered clinical trials investigating EV-based therapeutics (modified from [41] with permission)
Disease number
of patients
clinical trial
(CT) phase
Source cell-type/
application route
Modified/unmodified
vesicle type
Results
References
Melanoma
Stage III/IV,
metastatic
n = 15
CT Phase I,
open label
Autologous
monocyte-derived
Dendritic cell EVs
s.c. inj.
MAGE3 loaded
DC-EVs
Proof of feasibility and safety; toxicity < grade II
Maximum tolerated dose not reached, 1 partial,
1 minor, 1 mixed response and 2 stable disease
Escudier et al. [15]
Non-small cell
lung cancer
Stage IIIb,
n = 4
Stage IV, n = 9
CT Phase I,
open label
Autologous
monocyte-derived
Dendritic cell EVs
s.c. and intradermal inj.
Peptide loaded
Feasibility and safety; toxicity < grade I–II, 9/13
Completed therapy, DTH against MAGE peptides
In 3/9, specific T cell response in 1/3, NK lytic
Activity increased in 2/4
Morse et al. [16]
Colon Cancer
Stage III or IV,
n = 40
CT Phase I,
open label
Autologous
ascites-derived EVs
(Aex)
s.c. inj.
Unmodified
± GM-CSF
Feasibility & Safety, Toxicity Grade I-II,
TU-specific
Cytotoxic T Cell Response in Aex + GM-CSF
group (n = 2)
Dai et al. [30]
Colon Cancer
n = 35
(estimated
enrolment)
CT Phase I,
open label
Plant nanovesicles
Not mentioned in NCT
registry:
Route of application
Curcumin, exogenous
loading
NCT01294072
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