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TisXell -Generated Bone Grafts – A Pre-clinical Study. Dr Mark Chong National University of Singapore Dept of Obstetrics and Gynaecology. Why Bone?. 2 nd most transplanted tissue 1 million cases annually in US alone Current treatment: Autograft: Site morbidity

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Tisxell generated bone grafts a pre clinical study

TisXell-Generated Bone Grafts – A Pre-clinical Study

Dr Mark Chong

National University of Singapore

Dept of Obstetrics and Gynaecology


Why bone
Why Bone?

  • 2nd most transplanted tissue

    • 1 million cases annually in US alone

  • Current treatment:

    • Autograft: Site morbidity

    • Allograft: Donor shortage, immune rejection

  • Solution: Tissue Engineering


How do we engineer bone
How do we engineer Bone?

Mesencymal stem cells (MSC)

  • Resorbable scaffolds + osteogenic cells

  • Mature in bioreactor  TisXell System

  • Note:

    • Function of bone is primarily structural

    •  low hanging fruit


Tisxell enhances bone formation
TisXell enhances bone formation

Day 0

Day 14

Day 28

Increased cellular proliferation

Increased mineralisation

TisXell


Bioreactor enhances bone formation
Bioreactor enhances bone formation

Day 0

Day 14

Day 28

Increased viability

Increased cellular proliferation

Increased mineralisation

TisXell

Live

Dead



Rat femoral defect model
Rat Femoral Defect model

Created 7 mm defect

Press-fit 8 mm graft




Mineralisation confirmed by histology

S

S

S

S

S

S

Mineralisation confirmed by histology


Findings from rodent studies
Findings from rodent studies

  • TisXell stimulates bone formation

    • 5.7 x more mineralisation than static

  • TisXell generated bone grafts are highly efficacious

    • Rapid healing of fracture within 3 months vs non-union


Scaling up
Scaling up

Mesencymal stem cells (MSC)

Endothelial Progenitor Cells (EPC)

Minipig model

Larger volume, anticipate issues of vascularisation

Introduce endothelial progenitor cells (EPC) into cellular mix


Cells remain viable and randomly distributed
Cells remain viable and randomly distributed

 TisXell supports co-culture of different cell types

MSC

EPC


Minipig critical size defect model
Minipig Critical-Size Defect Model

  • 18 mm segmental defect in tibia

  • Monitor over 12 months:

    • X-ray, CT, angiography



Ct angiography rapid vascularisation of fmsc epc group
CT Angiography: rapid vascularisation of fMSC-EPC group

MSC

fMSC-EPC

1 mth

3mth

1 mth


Findings so far
Findings so far…

6 pigs implanted with TisXell cultured TEBG

All pigs survived; no adverse reaction

Mineralisation and bridging evident at 3 mths in MSC group; 1 mth in fMSC-EPC group

Studies to continue for long-term safety data (12 months)


Conclusion
Conclusion

TisXell provides a controlled and conducive environment for generating TEBG implant

Potent osteo-stimulatory cues

Efficacy demonstrated in rat model

Potentially faster bone regeneration and vascularisation in minipig model

Preparatory work with clinicians for Clinical Phase I trial


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