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SURGICAL MANUAL
Defect Assessment and Biopsy Procurement
Cell Implantation Procedure
Tom Minas, M.D.
Edited by Lars Peterson, M.D., Ph.D.
Written by
Surgical Manual Acknowledgment
The surgical technique represented in this manual is acknowledged to its developers:
Lars Peterson, M.D., Ph.D.; Mats Brittberg, M.D., Ph.D.; Anders Lindahl, M.D., Ph.D.;
Anders Nilsson, M.D., Ph.D.; Olle Isaksson, M.D., Ph.D., and Claes Ohlsson, M.D., Ph.D. It is
their careful consideration, and analysis of experimental and clinical results which has contributed to the evolution of the surgical technique in this manual.
Careful patient selection, correct indications, meticulous surgical technique and an appropriate rehabilitation protocol are important for a satisfactory clinical result when using
autologous chondrocyte implantation.
I am indebted to Dr. Peterson for his time and openness in teaching and sharing his technique and thoughts on cartilage repair.
Tom Minas, M.D. M.S.
Manual Design and Medical Illustration by
Amy Matson Walts
Surgical Manual for the Implantation of
Cultured Autologous Chondrocytes
Written by
Edited by
Tom Minas, M.D. M.S.
Lars Peterson, M.D., Ph.D.
Assistant Professor of Orthopaedics
Harvard Medical School
Director Cartilage Repair Center
Brigham & Women’s Hospital
Boston, Massachusetts
Professor, Department of Orthopaedics
University of Gothenburg
Clinical Director Gothenburg Medical Center
Vastra Frolunda, Sweden
64 Sidney St. ◆ Cambridge ◆ Massachusetts ◆ 02139 ◆ USA
Carticel ® is a registered trademark of Vericel Corporation in the United States.
Defect Assessment and
Biopsy Procurement
Defect Assessment and
Biopsy Procurement
Radiographic Joint Assessment
Radiographic Joint
Assessment
In order for a patient to be considered
a candidate for the implantation of
Carticel, the knee joint must be free
from osteoarthritic conditions.
Radiographic assessment may provide
an indication of the presence of
osteoarthritis. If this condition is apparent, the patient should not be considered as a candidate for this technology.
Standing X-rays may provide evidence
to reach this conclusion. Radiographs
of the patient’s legs should include a
weight-bearing view at 45° of flexion,
and a second view in full extension.
If the X-ray interpretation is consistent
with generalized osteoarthritis, implantation of autologous cultured chondrocytes is not indicated.
Figure 1.1: Subtle lateral joint
space narrowing.
Normal image.
Figure 1.2:
Arthroscopic appearance of entire lateral tibial plateau.
Arthroscopic examination revealed generalized thinning,
with near complete cartilage loss on the lateral tibial
plateau.
4
MRI Assessment
MRI Assessment
MRI scans may be useful to reveal meniscal
pathology and/or detect bone bruising.
However, the resolution and sequences of
routine clinical scans may not be sensitive
enough to assess cartilage defects. This
patient had a normal MRI scan, but an
arthroscopic evaluation detected a large
chondral defect.
Figure 1.3: Medial Femoral Condyle (MFC)
Scope arthroscopic assessment shows a
lesion on the medial femoral condyle of
2cm x 1.5cm.
Figure 1.4: Negative MRI MFC
MRI reveals no cartilage abnormality.
5
Arthroscopic Assessment
Arthroscopic Assessment
Determine patient candidacy for treatment. Joint condition, concomitant pathologies, size, number and extent of
defects are critical factors in this consideration.
Defect Assessment
The implantation of autologous cultured chondrocytes requires all damaged, loose, undermined and unhealthy
femoral articular cartilage surrounding the defect to be removed. The complete extent and size of the defect must
be determined to assure that an appropriate cell volume is provided at the time of implantation. Defects must be
surrounded by healthy, stable cartilage in order to maximize success.
Figure 2.1
Figure 2.2
Carefully probe to assess quality of cartilage and rule out undermining.
6
Arthroscopic Assessment
Arthroscopic Assessment
Figure 2.3
Hyperflexed;
Posterior lesion evident.
Create standard arthroscopic
1 portals,
medial and lateral.
Hyperflex the defect knee to expose
2 entire
condylar surface.
Figures 2.3 and 2.4
Carefully inspect all articular
3 cartilage,
tibial plateaus, femoral
condyles, patella and trochlear groove.
Figure 2.5
Arthroscopically assess the patella4 femoral
joint for abnormal facet
Figure 2.4
MFC @ 70-90o;
Lesion 3cmL x 1cmW.
tracking and joint surface contact.
Using standard arthroscopic probe
5 examine
joint surface to determine
cartilage resiliency.
Carefully palpate fissures and tissue
6 surrounding
defect to determine
integrity of surrounding cartilage.
Figures 2.6 and 2.7
Joint assessment must rule out general7 ized
osteoarthritis. Inspect the opposing surface of each defect. Full thickness cartilage defects on opposing
articular surfaces, so called “bipolar
lesions” are consistent with
osteoarthritis and contraindicated for
autologous cultured chondrocyte
implantation.
Figures 2.8 and 2.9
Figure 2.5
Full-extension MFC
and MTP. Carefully
exam tibial surface to
rule out kissing lesions.
Figure 2.6
18 mos. MFC after drilling;
Tissue delamination.
Fibrocartilage repair.
7
Defect Assessment
Figure 2.7
MFC 1.5 x 2.0mm
Contained lesion with
loose flaps
Defect Assessment
Isolate each individual defect. Assess
1 tissue
surrounding defect.
The borders of the defect must be
surrounded by healthy cartilage of
2 normal
thickness, measuring at least
Figure 2.8
Clearly not acceptable
reciprocal damage for
implantation of
autologous cultured
chondrocytes
2 to 3mm. This thickness is necessary
to accommodate suture fixation of a
periosteal patch to the defect for
subsequent implantation of autologous
cultured chondrocytes. Verify that the
most posterior margin of the defect is
visible and meets these requirements.
Using a graduated probe, measure the
3 dimensions
anterior-posterior and medial-lateral
of each defect. Accurate
measurement of each defect is critical
to ensure adequate cell volume is provided for implantation. Record defect
measurements on the Patient Biopsy
Transmittal Notice included in the
Vericel Corporation Cartilage Biopsy
Transport Kit.
Figure 2.10
Figure 2.9
Generalized degeneration;
Uncontained borders
Figure 2.10
Use a 5mm probe tip
to measure contained
defect dimensions.
8
Instrumentation List
Instrumentation List
for Biopsy Procurement
■
■
■
■
■
Notchplasty Gouge
Standard 6mm Ringed Curettes
Non-Toothed Graspers
Standard Arthroscopy Equipment
Vericel Corporation Cartilage Biopsy Transport Kit
9
Biopsy Procurement
Biopsy Procurement
Step 3: Medial
Superior Ridge
Notice: Before harvesting tissue,
ensure that the Vericel Corporation
Cartilage Biopsy Transport Kit is
present. Verify that the biopsy
medium is not expired by inspecting
the expiration date noted on the
biopsy container. Also check the
container for leakage and the
medium for any particulates,
turbidity and color change.
Cartilage tissue must be harvested
from a lesser load bearing,
non-articulating surface. The superior
medial or lateral femoral articular
cartilage margins are recommended
as tissue procurement sites.
The tissue may be procured using
either a ring curette or a curved
notchplasty gouge.
The medial side is recommended as
the preferred biopsy site. It is easy to
access and provides thick cartilage,
which generally yields a superior
biopsy. Rule out patellar overhang from
the facets prior to biopsy, starting at
the cartilage bone junction. Harvest
as close to the synovial junction
as possible.
Step 4: Lateral
Superior Ridge
Careful assessment is required when
obtaining biopsies from the lateral side
of the femoral condyle. Again, rule out
patellar overhang prior to biopsy. The
cartilage is usually thinner, and if
harvested too far superiorly, it may
be fibrous tissue.
To remove cartilage biopsy, grasp
cartilage at the site of attachment with
non-tooth graspers, and twist and pull
to dislodge specimen. Obtain 2 fullthickness biopsies measuring 5mm x
8mm.
Step 5: Obtain 2 full-thickness
biopsies measuring 5mm x 8mm.
8mm
5mm
200-300mg
10
Biopsy Procurement
Using Ring Curette
Place leading edge of a 6mm ring
1 curette
at superior aspect of the
medial or lateral articular margin of
the femoral condyle
Lesion
Apply pressure until the sharp edge
2 cartilage
penetrates the full-thickness of the
down to subchondral bone.
Biopsy of healthy
cartilage
Using a twisting or “wiggle” motion,
draw the curette down the margin to
create a crescent-shaped specimen.
Leave the distal portion of the biopsy
3 attached
to enable retrieval from the
joint using a non-tooth linear grasper.
The biopsy must be full-thickness and
4 should
include a small sample of bone.
Articular Surface
Superficial Tangential
Zone (10-20%)
Middle Zone (40-60%)
Deep Zone (30%)
Calcified Cartilage
Tide Mark
Subchondral Bone
Cancellous Bone
Step 1:
Medial superior ridge
Full-thickness specimens including small bone sample.
Step 2: Engage back of curette.
Step 3: Create a dowel of cartilage
with a side-to-side motion.
Step 4: Keep the distal stump
intact. Remove with a nontooth grasper.
11
Biopsy Procurement
Using Notchplasty Gouge
Place the leading edge of a notchplasty
1 distal
gouge approximately 10mm-15mm
to the superior aspect of the
medial or lateral articular margin of
the femoral condyle.
2
Apply pressure to ensure the sharp
edge penetrates the full-thickness of
the cartilage down to subchondral
bone. Using a twisting or “wiggle”
motion, push the notchplasty gouge
proximally towards the superior aspect
to create a crescent-shaped specimen.
Step 1
Leave the proximal portion of the
3 from
biopsy attached to enable retrieval
the joint using a non-tooth linear
grasper.
Step 3: Angle the gouge on
both sides, to ensure the
superior proximal attachment
is very thin.
Step 2: When using the gouge, engage the
cartilage and create a dowel with a
side-to-side motion.
12
Biopsy Procurement
Using Notchplasty Gouge
at Intercondylar Notch
The intercondylar notch is an
1 alternative
biopsy site.
When harvesting from this location,
2 flex
the knee 30° to 40° and then fully
extend while observing arthroscopically to ensure that cartilage is not taken
from a weight bearing area.
Start at the superior-lateral aspect
3 knee),
(approximately 11:00 position on a left
and work down the lateral wall.
Place sharp edge of notchplasty gouge
4 approximately
5mm lateral to the
articular cartilage margin of the lateral
notch wall and systematically begin to
incise the outline of the biopsy to
be taken prior to using the gouge to
elevate the chondral biopsy.
Step 4: Entering from the medial portal, remove 5mm of
cartilage from the lateral half of the notch.
Leave the distal portion of the biopsy
5 attached.
Remove tissue with a non-tooth
6 grasper.
Step 6: Leaving the distal stump attached, reach in with a
non-tooth grasper and remove the cartilage piece.
13
Biopsy Procurement
Packaging Biopsy
NOTE: The exterior of the container is
NOT STERILE.
Remove biopsy container from Cartilage
1 Biopsy
Transport Kit.
Following sterile technique protocols,
2 carefully
place each biopsy sample into
biopsy container containing transport
media and seal with cap.
read Cartilage Biopsy Transport
3 KitCarefully
Instructions for Use provided with kit.
Package in accordance with shipping and
handling instructions.
Complete all sections of Cartilage Biopsy
4 Transmittal
Notice included in Cartilage
Biopsy Transport Kit and sign form.
Include one copy of hospital’s / clinic’s
5 Patient
Face Sheet in Cartilage Biopsy
Transport Kit.
Immediately call Vericel Corporation
6 Customer
Care
at
1-800-453-6948 (USA)
to arrange for biopsy pick-up.
14
Cell Implantation
Procedure
Cell Implantation
Procedure
Instrumentation List
Instrumentation List
for Cell Implantation
Defect Preparation
■ Small Ringed Curettes 4mm or 6mm
■ Epinephrine
■ Neurosurgical Gauze Patties (Spinal)
■ Thrombin Spray or Gel
■ No.15 Surgical Blade
Periosteal Patch Harvest and Fixation
■ Periosteal Elevator
■ 6mm, Curved or Blunt Tip Elevator
■ No.15 Surgical Blade
■ Ruler (sterile)
■ Ink Marker (sterile)
■ Non-toothed Tissue Forceps
■ 6.0 and 5.0 Coated Vicryl, Dyed Suture
■ P-I Cutting Needle
■ Optional Needles (PC-1, P-2)
■ Needle Driver
■ Sterile Mineral Oil
■ Dissecting Scissors
Water Tight Testing
■ 1cc Syringe
■ Sterile Saline
■ 18 Gauge Blunt Tip Needle
■ IV Catheter, 18 gauge x 2”
Fibrin Glue Application
■ Applicator Assembly 1cc
■ 26 Gauge x 3” Applicator Tip
■ Fibrin Glue
CARTICEL Implantation
■ IV Catheter 18 Gauge x 2”
■ Alcohol Swab
■ Carticel Vial
16
Factors and Recommendations
Predisposing Factors
To create a favorable environment for healing, predisposing factors must be addressed prior to cell
implantation. These conditions include:
Meniscal Pathology:
Unstable meniscus tears should be repaired or resected. If the patient has had a total
meniscectomy, absent meniscus should be reconstructed.
Cruciate Instability:
Instability of the knee may adversely affect the success of the procedure and should be corrected.
The anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact. It
is recommended that cruciate deficiencies be corrected.
Malalignment:
Abnormal weight-distribution within the joint may adversely affect the success of the procedure
and should be corrected. The tibial/femoral joint should be properly aligned. When treating
trochlear defects, abnormal patellar mechanics should be assessed and corrected.
Tourniquet Use
Recommended options for use:
1) Use tourniquet throughout the entire procedure.
2) Lower tourniquet after periosteum procurement.
3) Do not use a tourniquet.
Hemostasis of the defect bone bed is a critical component to the success of the surgical procedure and must
be achieved prior to cell implantation.
The effectiveness of hemostatic agents applied to the defect bed can be assessed by lowering the tourniquet
immediately after harvesting the periosteum. Complete hemostasis must be achieved prior to periosteal fixation
and cell implantation.
Hemostasis
Bleeding through the subchondral plate must be controlled. Epinephrine is recommended as a first-line hemostatic
agent as follows:
1) Mix a vial of 1-1000 epinephrine with 20cc of sterile saline.
2) Soak neuropatties in epinephrine solution, then pack defect with soaked patties.
3) If a second agent is needed to achieve hemostasis, Thrombin, either in gel form or spray, is
recommended. Apply Thrombin only at the point of penetration or source of bleeding.
17
Defect Preparation
Defect Preparation
Arthrotomy
To treat an isolated defect on the medial
or lateral femoral condyle, a mini-arthrotomy
may be performed. When treating multiple
defects or defects that are more difficult
to access, a traditional medial arthrotomy
is recommended.
Use a sharp blade to circumscribe the defect
back to healthy cartilage. Eliminate all clefts,
fissures, and cartilage that is undermined or
detached from subchondral bone.
To further assess the cartilage excision,
focus on: discoloration, irregular surface
areas, absence of normal resiliency, thinning
cartilage, and gritty texture.
Healthy cartilage of normal thickness and
resiliency must surround the defect. If the
defect is close to the intercondylar notch and
no cartilage rim is available, the periosteum
can be sutured to the synovial lining.
Use an open curette to excise all damaged
or unhealthy cartilage from the perimeter of
the defect. Remove as little healthy cartilage
as possible.
The base of the defect must be carefully and
completely debrided by removing all fibrous
tissue and cartilage remnants. Use a curette
to scrape defect base to expose calcified
cartilage layer. Take care not to penetrate
subchondral bone.
Step 1: Use an open ring curette to excise damaged
cartilage from the defect.
Good stable vertical borders.
Step 5: The bone plate must be intact. Remove
fibrous covering.
Key points:
Criteria for Optimal Defect Bed: Cartilage surrounding
the defect is healthy with sharp, vertical walls surrounding
the entire defect. This will aid suturing the periosteum, and
the containment of implanted cells.
The subchondral bone plate is completely intact, and free of
fibrous tissue, and bleeding.
Criteria for Optimal Periosteum:
Oval or circular shaped defects simplify suturing periosteum,
and help to secure a watertight seal.
Periosteum must remain moist throughout the procedure.
The incision exposing the cartilage defect must allow
adequate room for securing the periosteal patch.
18
Defect contained by healthy cartilage.
Periosteum Procurement
Step 1: Measure the defect at its widest point.
Add 2mm to both the vertical and horizontal
measurement.
Periosteum Procurement
Use a disposable ruler to accurately
1 measure
the defect at its widest
(medial to lateral, and superior to
inferior) points. A sterile paper
template may be used to aid in marking
difficult defect shapes.
2mm to both vertical and horizon2 Add
tal measurements to compensate for
shrinkage of the periosteum after
removal from the bone surface. Keep
the periosteum moist to decrease
shrinkage.
The tibia provides optimal periosteal
3 tissue.
Obtain this tissue from the
Step 3: Insertion of pes
anserinus.
proximal medial anterior cortex of the
tibia with a separate incision approximately 2.5cm below the pes anserinus.
Incision located 2.5 cm below
the pes anserinus.
19
Periosteum Procurement
Identifying the Cambium Layer
It is important to identify the cambium
surface when applying the periosteum to
the defect area. To distinguish the cambium
side of the periosteum from the outer
fibrous side, use a sterile ink pen to mark
the center of the tissue to be harvested,
prior to removing from the bone.
Step 1: Start with the edges
around the periphery.
With a sterile ink pen, use the recorded
measurements and mark the widest
dimensions of the corresponding defect and
then grossly outline the shape of the patch
with the ink pen.
To allow for complete exposure of tissue,
use a scissor dissection and a damp sponge
to carefully remove all tissue layers superficial to the periosteum.
Step 2: Angle the periosteal
elevator. Do not damage the
subchondral bone.
Use a number 15 surgical blade to cut
sharply around the marked outline down to
the bone.
a small periosteal elevator to create
1 toanUseproximal.
edge around the borders. Work distal
If the tissue is laminated, it
may be in the distal portion of the pes.
Care must be taken not to damage the
2 delicate
cambium layer of the periosteum when removing tissue from the
bone.
Angle the elevator and carefully push
3 the
periosteum off the bone, holding
elevator as parallel as possible to the
bone surface. Roll tissue up and away
from the bone to avoid damage. Avoid
gouging the underlying bone when
removing the tissue.
Key points:
Keep periosteum and surface cartilage moist at all times. Place periosteum
on damp sponge.
A sterile paper template may aid periosteal patch sizing.
When treating multiple defects, mark each periosteal patch specifically for
its intended location.
If the periosteum rips, it can be sutured; if it is too small, a second piece
of tissue must be harvested and sutured to the original piece. Suture the
two pieces of periosteum together, end to end. Do not overlap the tissues.
Fibrin glue may be applied to create a watertight seal.
20
Step 3: Elevate periosteum.
Flap may roll or curl up; gently
straighten after removal.
Periosteum Fixation
Periosteum Fixation
Tourniquet
♦ When using a tourniquet, let tourniquet down and
closely inspect the base of each defect to confirm
that hemostasis has been achieved.
♦ If hemostasis has not been achieved, apply thrombin in pinpoint fashion at the source of bleeding.
Step 2
1
Step 4:
Start by anchoring
down the corners.
Suture fixation
Determine proper orientation of the periosteum
and cover defect with cambium layer down (facing
towards the defect). Identify cambium layer by:
♦ Ink marked periosteum.
♦ Cambium layer will appear glossy.
♦ When inspected closely, the outer fibrous surface
of the periosteum will reveal visible fatty tissue.
The periosteum must fit into, and not overlap, the
2 edges
of the defect.
Trim away excess tissue which overlaps cartilage
3 surface
prior to securing it to the cartilage.
4 Anchor periosteum at 4 corners of the defect.
A 6.0 Vicryl suture on a P-1 cutting needle is
5 recommended
to suture the periosteum to the
defect rim. A variety of needle sizes and
configurations may be needed depending on
cartilage quality and/or defect location.
Lubricated sutures are necessary for passage
6 and
through cartilage. Prior to use, coat or soak sutures
needle in sterile glycerin or mineral oil.
Angle needle towards periosteum surface
7 approximately
2mm from its edge and pass
through tissue into the cartilage wall following
curvature of needle. Needle must enter cartilage
wall approximately 2mm below the condylar
surface and have a 3mm bite.
Tie-off sutures and place knots on the side of the
8 periosteum
ensuring knots are not prominent to the
condylar surface.
Continue to place interrupted sutures in a
9 diametrically
opposed pattern (z-pattern).This will
evenly distribute the tension of the periosteum and
provide a secure, watertight fit.
Step 7: Angle the needle toward the surface to obtain a
cartilage bite. Tie knot on side of periosteum, not on the
cartilage rim.
21
Periosteum Fixation
(continued)
Space sutures approximately
3-4mm apart to achieve a
10 watertight
seal.
Leave an opening large enough to
an 18 gauge catheter
11 ataccommodate
the most superior point of the
defect. This opening will be used to
test the periosteal integrity by
injecting saline under the periosteum to test for leakage prior to
cell implantation.
3mm
superior opening
3 to 4mm
Key Points:
Cut well-lubricated sutures to 8 inches.
Follow the path and curvature of needle during placement. Do not force the path of the needle; this may damage
the cartilage or periosteum.
Periosteum and suture knots must be flush and not prominent to the surface of the defect; to assess knot placement,
run finger over the periphery of the defect. If knots are prominent, push them off the cartilage rim toward the
center of the periosteum.
To test suture knot tightness, use forceps and lightly pull the sutures away from the cartilage. If the knots move or
appear loose, they must be tightened.
If no cartilage rim is available, suture the periosteum to the synovial membrane. Placement of sutures needs to be
closer together to ensure watertightness.
Smaller needles (P-2) are recommended when suturing into synovium. With very soft cartilage, longer needles (PC-1)
will provide a longer bite.
A vascular needle driver may be helpful when suturing the periosteum to a deep posterior defect.
22
Watertight Testing
Step 1:
Ensure that the superior opening
accommodates an 18 gauge
catheter.
Periosteum Watertight
Integrity Testing
A watertight seal serves two functions:
prevents implanted chondrocytes from
leaking out of the defect; and seals the
defect from interior hemoarthrosis.
a secure periosteum has a flush and taut
appearance over the defect.
To test periosteum’s watertight
1 integrity,
use an 18 gauge angiocatheter
tip or blunt needle to inject sterile
saline into the defect through the
superior opening.
for leakage around the perimeter
2 ofInspect
the defect at the periosteum and
cartilage border.
If leakage is apparent, additional sutures
3 will
be necessary.
Once a watertight seal is achieved,
4 aspirate
all remaining saline from under
periosteum. A dry defect bed enhances
chondrocyte adherence and prevents
dilution of cells.
Step 2:
Carefully check for leakage
at the inferior apex of the
defect.
23
Autologous Fibrin Glue Application
If you choose to use autologous fibrin glue, the following instructions are provided for the administration.*
Autologous Fibrin Glue
Fibrin glue consists of autologous
cryoprecipitate and a mixture of
Thrombin and calcium chloride.To
prepare, please consult Spotnitz
WD, Mintz PD, Avery N, Bithell TC,
Kaul S, Nolan SP, “Fibrin glue from
stored human plasma” The
American Surgeon, 1987, Vol. 53,
pages 460-462 regarding its
preparation.
1
Apply fibrin glue one
drop at a time around
the defect periphery.
Application of Fibrin Glue
Fibrin glue may be applied to the
periphery of the defect at the
periosteum-cartilage margin.
When using autologous blood, the
2 amount
of fibrinogen will vary from
patient to patient. The fluid consistency,
and time to congeal and set will vary.
Use a double-barreled syringe. Bring a
3 single
drop of fibrin glue to the tip of
the Y-needle.
When fibrin glue starts to congeal,
4 place
a drop on a plastic surface and
note set time. This will indicate set
time for glue solution.
Proceed to defect periphery and again
5 bring
a single drop to the tip of the
Y-needle and hold for several seconds.
Apply drops as glue begins to congeal,
one at a time, along entire suture line.
If periosteum is of poor quality or
6 contains
tears, apply fibrin glue to the
surface. Do not allow to leak under
periosteum.
Additional fibrin glue is
needed when suturing
to soft tissue.
Once fibrin glue application is complete
and glue is dry, use syringe to inject
approximately .4cc of air under patch.
This will reveal if the periosteum is
adhered to the defect bed, and if there
is adequate space beneath the periosteum for cell implantation.
Key Points:
*In the databases evaluated for the approval of
Carticel, over 90% of patients had fibrin glue
applied during implantation of autologous
cultured chondrocytes to prevent cell leakage.
24
Y-needle may clog. Ensure additional units are readily available.
Fibrin glue will dry in approximately 10 to 15 seconds.
Cell Aspiration
Cell Aspiration
Exterior of the Carticel vial containing the
cultured cells is NOT sterile. Follow strict sterile
technique protocols.
Match the patient name and ID number on
the certificate of analysis to the patient
name on your patient chart and the patient
ID number on the shipping box, transport
cylinder and vial. See the figure to the left
identifying the location of the patient ID
number on each label.
Vericel
When treating a defect which requires multiple vials of
cells, aspirate and inject one vial at a time.
Remove red plastic lid from vial. Wipe the vial surface
1 and
lid with alcohol.
Inspect vial contents for particulates, discoloration or
2 turbidity.
The cellular product appears as a yellowish
clump in the bottom of the vial. Do not administer if
contents appear turbid prior to cell suspension.
While holding vial in a vertical position, inset metal
3 needle
of the intraspinal catheter into the vial. The
needle must be positioned just above the fluid level.
Slowly remove the inner needle from the catheter,
leaving the flexible tip behind. Attach tuberculin
syringe to catheter.
the catheter tip into the medium and position
4 Lower
just above cell pellet. Aspirate all the medium from the
vial leaving only the cell pellet behind. Slowly expel
medium back into the vial. This action will break cell
pellet and resuspend the cells in the medium.
the catheter tip to the base of vial and aspirate
5 allLower
contents into syringe, leaving the vial empty. Slowly
inject contents into the vial again. This will assure
complete suspension of the cells. Repeat the steps as
needed to ensure all cells are resuspended. Cell
resuspension is complete when cell particles are no
longer apparent, and the medium in a consistent,
“cloudy” mixture. Aspirate all contents of vial into
syringe. Always hold syringe vertical to keep an air
pocket at the proximal end of syringe.
at start
cell pellet
aspirate
medium
resuspended
cells
Keeping syringe in upright position (tip pointing down),
6 grip
the catheter and syringe at their junction to
prevent separation. Slowly extract the catheter from
vial while holding plunger in place to avoid drawback of
cells.
When treating a defect which requires multiple vials of
7 cells,
aspirate and inject one vial at a time.
25
Cell Implantation
Cell Implantation
1 Always hold syringe vertical to keep an air pocket at the proximal end of the syringe.
catheter tip through superior opening of periosteum. Advance catheter to the most inferior aspect
2 ofInsert
the defect.
Slowly inject a cell dose (see Dosage and Administration section of the package insert) while moving
3 the
catheter tip from side to side and withdraw the catheter proximally. This will ensure an even distribution
of the cells throughout the defect.
When treating multiple defects with only one vial, cell volume must be distributed proportionately with
4 respect
to defect size.
Complete the implantation by closing the superior opening of the periosteum with additional
5 sutures
and fibrin glue.
Key Points:
Use luer lock twist to avoid separation of catheter from syringe.
Always hold syringe with catheter tip facing down.
Evenly disperse cells over entire base of defect.
To avoid abrading or damaging the periosteum with the catheter, two openings in the periosteum
may be necessary to inject the cells.
26
Notes
27
Notes
28
Vericel Corporation
64 Sidney Street
Cambridge, MA 02139
USA
Tel: 800-453-6948
Fax: 844-333-2847
www.carticel.com
65021.G
02/2015