Objective
To
evaluate
efficacy
and
safety
at
5
years
after
treatment
with
hydrogel-based
autologous
chondrocyte
implantation
(ACI)
for
large
cartilage
defects
in
the
knee.
Design
Prospective,
multicenter,
single-arm,
Phase
III
clinical
trial.
ACI
was
performed
100
patients
focal
full-thickness
ranging
from
4
to
12
cm
2
size.
The
primary
outcome
measure
responder
rate
(defined
as
improvement
by
≥10
points)
using
Knee
Injury
Osteoarthritis
Outcome
Score
(KOOS).
Results
preoperative
overall
KOOS
39.8
points
continuously
increased
84.7
(mean
increase
44.1
points,
95%
CI
=
40.4-47.9,
P
<
0.0001).
study
endpoint
(i.e.,
a
of
>40%)
descriptively
met
each
assessment
timepoint
3
months
(Month
3:
75.5%,
65.6-83.8;
Year
2:
93.0%,
86.1-97.1,
5:
92.8%,
85.7-97.0).
International
Documentation
Committee
(IKDC)
subjective
objective
scores
quality
life
assessments
(EQ-5D-5L)
supported
results
seen
KOOS.
failure
1%.
All
treatment-related
adverse
events
were
mild
or
moderate
intensity
mostly
occurred
within
first
year
treatment.
Conclusions
Hydrogel-based
has
been
shown
be
safe
effective
option
knee
sustained
up
demonstrated
consistent
clinically
relevant
improvements
all
investigated
variables.
No
remarkable
issues
noted.
Gels,
Год журнала:
2025,
Номер
11(3), С. 199 - 199
Опубликована: Март 13, 2025
Cartilage
damage
is
common
in
sports
injuries
and
cartilage-related
diseases,
such
as
degenerative
joint
rheumatic
disorders.
Autologous
chondrocyte
implantation
(ACI)
a
widely
used
cell-based
therapy
for
repairing
cartilage
clinical
practice.
In
this
procedure,
patient’s
chondrocytes
are
isolated,
cultured
vitro
to
expand
the
cell
population,
then
implanted
into
damaged
site.
However,
expansion
of
on
standard
2D
culture
surfaces
leads
dedifferentiation
(loss
phenotype),
delivery
detached
cells
has
proven
be
ineffective.
To
overcome
these
limitations,
matrix-assisted
ACI
(MACI)
procedure
was
developed.
MACI,
matrices
hydrogels
microspheres
carriers
or
scaffolds
deliver
expanded
chondrocytes,
enhancing
viability
precision
delivery.
streamline
two
key
steps
MACI—cell
delivery—this
study
aims
investigate
various
configurations
gelatin-based
their
potential
support
both
single
step.
This
evaluated
gelatin
(Gel
MS),
micronized
photo-crosslinked
GelMA
microparticles
(GelMA
MP),
bulky
containing
HG).
Cell
growth,
maintenance
phenotype,
extracellular
matrix
(ECM)
production
were
assessed
pellet
cultures
grown
on/in
carriers,
compared
with
tissue
culture-treated
polystyrene
(TCP).
Our
results
demonstrate
that
normal
human
knee
articular
exhibit
robust
growth
Gel
MS
form
aggregates
enriched
glycosaminoglycan-rich
ECM.
outperformed
MP
HG
carrier
by
supporting
long-term
reduced
Objective
To
evaluate
efficacy
and
safety
at
5
years
after
treatment
with
hydrogel-based
autologous
chondrocyte
implantation
(ACI)
for
large
cartilage
defects
in
the
knee.
Design
Prospective,
multicenter,
single-arm,
Phase
III
clinical
trial.
ACI
was
performed
100
patients
focal
full-thickness
ranging
from
4
to
12
cm
2
size.
The
primary
outcome
measure
responder
rate
(defined
as
improvement
by
≥10
points)
using
Knee
Injury
Osteoarthritis
Outcome
Score
(KOOS).
Results
preoperative
overall
KOOS
39.8
points
continuously
increased
84.7
(mean
increase
44.1
points,
95%
CI
=
40.4-47.9,
P
<
0.0001).
study
endpoint
(i.e.,
a
of
>40%)
descriptively
met
each
assessment
timepoint
3
months
(Month
3:
75.5%,
65.6-83.8;
Year
2:
93.0%,
86.1-97.1,
5:
92.8%,
85.7-97.0).
International
Documentation
Committee
(IKDC)
subjective
objective
scores
quality
life
assessments
(EQ-5D-5L)
supported
results
seen
KOOS.
failure
1%.
All
treatment-related
adverse
events
were
mild
or
moderate
intensity
mostly
occurred
within
first
year
treatment.
Conclusions
Hydrogel-based
has
been
shown
be
safe
effective
option
knee
sustained
up
demonstrated
consistent
clinically
relevant
improvements
all
investigated
variables.
No
remarkable
issues
noted.
