Table 9.1
(continued)
Disease number
of patients
clinical trial
(CT) phase
Source cell-type/
application route
Modified/unmodified
vesicle type
Results
References
Type I Diabetes
n = 20
(estimated
enrolment)
CT Phase I,
open label
Umbilical cord blood
(allogeneic) MSC-EVs
Not mentioned in NCT
registry:
Route of application
Unmodified
NCT02138331
Non-small cell
lung cancer
n = 22
CT Phase II,
open label
Autologous IFN-g
matured
Monocyte-derived
dendritic cell EVs
Intradermal inj.
Peptide loaded
One patient exhibited a grade 3 hepatotoxicity.
Seven patients (32%) experienced stabilization
of > 4 months: the primary endpoint (
! 50%
patients > 4 months) was not reached. No
induction of T cell responses, but an increase in
NKp30-dependent NK cell functions were
evidenced in a fraction of these NSCLC patients
presenting with defective NKp30 expression
NCT01159288
Besse et al. [45]
Malignant
Pleural Effusion
n = 30
(estimated
enrolment)
CT Phase II,
open label
Tumor cell-derived
microparticles used as
vectors for
chemotherapeutic drugs
Pleural or peritoneal
cavity
Chemotherapeutic
drugs, exogenous
loading
NCT01854866
Abbreviations:
CT clinical trials;
DC dendritic cells;
DTH delayed type hypersensitivity;
GM-CSF granulocyte-macrophage colony-stimulating factor;
NIH,
National Institute of Health;
NK natural killer;
MAGE melanoma antigen;
TU tumor
174
S. Ha and D. S. Lee
(continued)
Disease number
of patients
clinical trial
(CT) phase
Source cell-type/
application route
Modified/unmodified
vesicle type
Results
References
Type I Diabetes
n = 20
(estimated
enrolment)
CT Phase I,
open label
Umbilical cord blood
(allogeneic) MSC-EVs
Not mentioned in NCT
registry:
Route of application
Unmodified
NCT02138331
Non-small cell
lung cancer
n = 22
CT Phase II,
open label
Autologous IFN-g
matured
Monocyte-derived
dendritic cell EVs
Intradermal inj.
Peptide loaded
One patient exhibited a grade 3 hepatotoxicity.
Seven patients (32%) experienced stabilization
of > 4 months: the primary endpoint (
! 50%
patients > 4 months) was not reached. No
induction of T cell responses, but an increase in
NKp30-dependent NK cell functions were
evidenced in a fraction of these NSCLC patients
presenting with defective NKp30 expression
NCT01159288
Besse et al. [45]
Malignant
Pleural Effusion
n = 30
(estimated
enrolment)
CT Phase II,
open label
Tumor cell-derived
microparticles used as
vectors for
chemotherapeutic drugs
Pleural or peritoneal
cavity
Chemotherapeutic
drugs, exogenous
loading
NCT01854866
Abbreviations:
CT clinical trials;
DC dendritic cells;
DTH delayed type hypersensitivity;
GM-CSF granulocyte-macrophage colony-stimulating factor;
NIH,
National Institute of Health;
NK natural killer;
MAGE melanoma antigen;
TU tumor
174
S. Ha and D. S. Lee
