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Fibroblast cell therapy enhances initial healing in recessive dystrophic epidermolysis bullosa wounds: results of a randomized, vehicle-controlled trial.
[dystrophic epidermolysis bullosa]
Fibroblast
cell
therapy
can
modify
disease
biology
in
recessive
dystrophic
epidermolysis
bullosa
(
RDEB
)
although
whether
it
improves
wound
healing
is
not
clear
.
To
assess
the
effects
of
injecting
of
allogeneic
fibroblasts
into
the
margins
of
chronic
erosions
in
individuals
with
RDEB
in
a
prospective
,
double
-blind
,
randomized
,
vehicle-controlled
phase
II
trial
.
Erosions
were
randomized
1
:
1
,
to
either
a
single
treatment
of
5
×
10
(
6
)
fibroblasts
per
linear
cm
of
erosion
margin
or
vehicle
.
All
subjects
continued
standard
wound
care
.
The
trial
sponsor
,
participants
and
study
outcome
assessor
were
masked
to
treatment
allocation
.
A
hierarchy
of
endpoints
germane
to
erosion
closure
was
assessed
.
Twenty
-
six
erosions
in
11
subjects
with
RDEB
were
injected
;
14
erosions
received
fibroblasts
and
12
vehicle
alone
.
A
single
series
of
injections
was
given
at
day
0
and
all
follow-up
visits
were
completed
.
Treatment
difference
between
fibroblasts
and
vehicle
was
-
23
.
5
%
[
95
%
confidence
interval
(
CI
)
-
3
.
5
to
-
43
.
5
,
P
=
0
.
025
]
at
day
7
,
-
19
.
15
%
(
95
%
CI
3
.
36
to
-
41
.
66
,
P
=
0
.
089
)
at
day
14
and
-
28
.
83
%
(
95
%
CI
7
.
97
to
-
65
.
63
,
P
=
0
.
11
)
at
day
28
.
Beyond
day
28
,
however
,
changes
in
mean
erosion
area
did
not
differ
significantly
between
the
two
groups
.
A
single
intradermal
injection
of
allogeneic
fibroblasts
increases
the
initial
rate
of
erosion
healing
in
subjects
with
RDEB
within
the
first
28
days
but
not
thereafter
.
Further
studies
are
needed
to
address
the
potential
benefits
of
retreatment
as
well
as
optimal
cell
delivery
.
Diseases
Validation
Diseases presenting
"recessive dystrophic epidermolysis bullosa"
symptom
child syndrome
dystrophic epidermolysis bullosa
junctional epidermolysis bullosa
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