Our experience in the treatment ofchondropathies with Bioseed ®-C and

chondrotissue®

Our Experience

• Autologus Chondrocyte Implantation

(ACI)

• Application of innovative

scaffolds (like substitutive

biological prostheses)

combined with microfractures

BioSeed -C

chondrotissue

BioSeed-C

3d stable polymeric scaffold ( 30X20X2mm)

Innovative stable fixation

ideal primary graft stability and biocompatibility

cell culture with autologous serum

transplantation possible 21 days after prior biopsy

cryopreservation possible

logistic assistance in whole Europe

Clinical Application BioSeed-C

- Debridement- Measuring- Sizing

Clinical Application BioSeed-C- Fixation with transosseous knots (Erggelet technique)

Clinical Application BioSeed-C

- Fixation withresorbable pins(SmartNail)

OUR EXPERIENCEFrom September 2006 until today

we have recruited 155 patients

122 transplantations; 14 biopsies with no transplantation (refusal/indecisiveness); 18 patients are waiting for a transplantation; 1 failed cell culture (*); 80 M - 42 F ( average age 38 years ); femoral condyle defects ( average size 3.5 cm2 ); current clinical follow-up: 36 months; traumatic (64 pts), degenerative (58 pts), OCD (2 pts) etiology; 15 pts. had already received other orthopaedic treatments; 120 cases by mini-arthrotomy and 2 by arthroscopy

OUR EXPERIENCE Diagnosis on the basis of attentive anamnesis,

objective examination and MRI

15 pts. treated with associated surgery procedures(3 LCA pro LARS – various meniscectomies)

MRI3-6-9 months

MRI3-6-9 months

MRI3-6-9 months

MRI3-6-9 months (PTE)

Rehabilitation program Very important for the therapeutical success: because of the new tissue

formation it is not possible to immediately return to sport activity;

Rehabilitation paths from the first post-OP day (CMP), different initial programs

according to the lesion site ( F/P, F/T, T/T )

FEMORO-TIBIAL LESIONS : without loading for 4 weeks and progressive

loading from the 5th to the 12th week (to full body weight). CMP (immediately 0°-

40° with weekly 30° increase). Immediate off-load muscular isometric

reinforcement ( with contractions). Return to low-medium contact sports after 6

months, to more intensive contact sports after 8-12 months.

Outcomes

Positive and encouraging

Clinical prospective study (C.Erggelet) – Surgery Dep. Freiburg University(November 2001- November 2004)

Outcomes

MRIs 6 months after surgery showed a good defect filling in all patients

Arthroscopic second-looks with biopsy 9 months after surgery showed hyaline-like cartilage tissue, with integration into the surrounding cartilage and bone.

OutcomesEVALUATION

24 months follow-up (80 patients)

IKDS score KOOS score CINCINNATI KNEE score

92% no or slightest pain when feeling the joint line of treated condyle; 77% improvement of pain symptomatology compared to pre-OP

evaluation; 82% return to full joint mobility.

chondrotissue “intelligent” scaffold, to be used

in combination with Pridie/Boeck

drilling or microfractures. For the

haemostasis and protection of the

underlying tissue in traumatic and

degenerative joint cartilage

defects

We have already performed 40

implantations

Regeneration of articular cartilage

In association with microfractures

One-step procedure

Easy application

Easy logistics

100% biological and absorbable

in 40-60 days

chondrotissue

Traditional marrow stimulating techniques

Traditional marrow stimulating techniques to treat traumatic or degenerative cartilage defects

Drilling or microfractures of subchondral bone

Articular bleeding Regeneration of a low quality tissue

(fibrocartilage)

Drilling or microfracture

Covering with intelligent scaffold

Haemostasis and protection-

Ideal 3d environment for

tissue regeneration

Optimal differentiation-formation of hyaline-like

cartilage

Protection of subchondral bone and surrounding cartilage

Traditional marrow stimulating techniques with application of a scaffold

size: 20 x 30 x 1.1 mm

Composed by:

Resorbable matrixpure polyglycolic acid (PGA), CE marked, class III

Hyaluronic acid, CE marked, class III

chondrotissue

scaffold

rehydratation: serum or physiologic solution

PGA matrix with mechanical stability

Protection of underlying tissue haemostasis 3D scaffold> stimulates cell distribution> differentiation high cell biocompatibility easy to use

Max traction force Fmax

1

10

100

Soft PGA Felt chondrotissue

New

ton

(N)

P = 0,751

chondrotissue

chondrotissueHyaluronic Acid

Natural biopolymer

Important for cartilage structure and function (organizes proteoglicans in joint cartilage)

Viscoelastic

sudden loading: shock absorber action of shear stress: lubrificant

Molecular filter: erythrocytes, leucocytes, oxygen free radicals

Chondrogenic differentiation

High cell biocompatibility

Preclinical studiesin vitro studies with horse stem cells

Hyaluronic acid helps tissue regeneration derived from stem cells!

chondrotissueCellular migration induced by serum and hyaluronic acid

chondrotissueIndications

focal traumatic and degenerative chondral defects degree III to IV of Outerbridge scale, bigger than 1,5 cm2

femoral condyle, patella, trochlea, tibial plateau, talus, acetabulum…

chondral defects that may be treated with marrow stimulating techniques:

• microfracturing• Pridie drilling• etc.

chondrotissueIndications

Microfracture, Pridie drilling

ACIProsthesis

control group (7 sheep):

- defect size: 11mm x 8mm x 1,1mm

- microfracture

Implant group (7 sheep):

- defect size: 11mm x 8mm x 1,1mm

- microfracture

- covering with chondrotissue and transosseous fixation

histology:

- 14 days, 3 Months, 6 Months

chondrotissueanimal study

chondrotissueanimal study

debridemant microfracture chondrotissue

winningthe serum

reconsti-tution

taking the blood sample

surgery

chondrotissueanimal study

microfracture and bleeding microfracture and covering

chondrotissueanimal study - after 3 months

inferior tissue formation

formation of hyaline like cartilage tissue

microfracture with chondrotissue®: 3 months after surgery

microfracture without covering: 3 months after surgery

chondrotissueanimal study – after 6 months

still inferior tissue formation

advanced hyaline like tissue formation

microfracture with chondrotissue®: 6 months after surgery

microfracture without covering: 6 months after surgery

chondrotissueanimal study – after 6 months

MicrofracturingBiopsy after 6 months

Bad quality regeneration tissue

chondrotissue®

Biopsy after 6 months

Hyaklin-like regeneration tissue

Collagene type II - coloration

Dr. T. ZantopMRI 12 months

Case Report - 12 monthsm, 35, lat. femoral condyle - traumatic 4cm² - arthroscopy

dimension

microfracturing

pins

Dr. T. Zantop

Case Report - 12 monthsf, 54, med. femoral condyle – degenerative 3cm² - arthroscopy

microfracturing

pins

dimension

MRI 12 months

Dr. A. Bergmann

Case Report - 7 monthsm, 43, lateral talus – 0,7 cm² - arthrotomy

Imm. 1 deep cartilage lesion(outerbridge 4, white arrow)

Imm. 2 cartilage repair tissue after 7 months

Smart Nail, PLA

How to fix BioSeed -C and chondrotissue ?

Erggelet knots Fibrin glue

* very stable* arthroscopy and arthrotomy* too long for patella (approx. 1.5 x 16 mm)

* with vycril 2-0* Not expensive* very stable* ideal for patella* possible only by arthroscopy

*arthroscopy and arthrotomy* appropriate for small defects, if possible not in weight-bearing areas

chondrotissueWe used this cell-free technique to treat patients

older than 50 with internal and external femoral

chondropathies of 3rd – 4th Outerbridge grade,

with or without femoral-patellar-tibial

chondropahies of inferior grade.

We collected some cases in tibial- talar

chondropathies using fibrin glue to fix the

scaffold.

chondrotissue

The surgical implantation technique, the

pre- and post-OP procedure as well as the

rehabilitation program are the same as for

autologous chondrocyte transplantations

chondrotissue- technique

• Perform debridement and microfracturing of subchondralbone

• Soak the scaffold with the patient´s own serum (2-3 ml)

• Cut to size to fit the defect

• Fix using the afore mentioned techniques

chondrotissue- Advantages

One-step procedure

Reduced costs

Relatively faster rehabilitation

Clinical short-term results are almost

overlapping to the ones obtained with the ACI

procedure

ConclusionsThe ACI is an effective treatment for

cartilage pathologies with precise indications, e.g. in the so called motivated “young old patients”.

Literature about the ACI procedure shows that the repair tissue has typical characteristics of hyaline cartilage (after 24 months – cartilage and tidemark regeneration).

Conclusions chondrotissue is though a valid alternative

considering clinical outcomes and costs.bioengineering opens new possibilities for

the treatment of complex tissue defects. The use of bioactive factors and genetic induction techniques will - hopefully –allow faster, high-quality, long-term solutions.

THANKS