1. Content In vitro characterization – of co.don chondrotransplant ® DISC Animal trial - feasibility Indications Background Manufacturing of co.don chondrotransplant ® DISC Application of co.don chondrotransplant ® DISC Autologous Disc-derived chondrocyte Transplantation (ADCT)
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5. Content In vitro characterization – of co.don chondrotransplant ® DISC Animal trial - feasibility Indications Background Manufacturing of co.don chondrotransplant ® DISC Application of co.don chondrotransplant ® DISC Autologous Disc-derived chondrocyte Transplantation (ADCT)
6. In vitro processing of disc-derived chondrocytes Sequester tissue Isolation of disc chondrocytes Expansion of disc chondrocytes Disc cells in monolayer Cell cultures Sequestrectomy
7. In vitro characterization of co.don chondrotransplant ® DISC low cell density high cell density Fig.: Proliferation curve. Proliferation of disc-derived cells
8. Phenotype of disc chondrocytes Anulus fibrosus (AF), Nucleus pulposus (NP) and Co-culture (CC) cultures: constant expression of biglycan , decorin , aggrecan , CEP68 , collagen types I and III decreasing expression of S100 in higher passages no expression of collagen type II Fig.: Decorin mRNA Expression in CC ML cultures. In vitro characterization of co.don chondrotransplant ® DISC M P1 P2 P3 P4 P5 P6 P7
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14. Positive BrdU-stained cell nuclei within ADCT-treated disc levels. Identification of transplanted BrdU-labeled disc derived cultured chondrocytes Animal trial
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16. x200 x100 Strong staining for collagen type II. Intercellular and p ericellular positive collagen type II staining Low expression of collagen type I Compositional restoration of the intervertebral disc ADCT-treated disc: Intact disc: Low staining for collagen type I. x25 x25 Animal trial x25 x25
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18. Content In vitro characterization – of co.don chondrotransplant ® DISC Animal trial - feasibility Indications Background Manufacturing of co.don chondrotransplant ® DISC Application of co.don chondrotransplant ® DISC Autologous Disc-derived chondrocyte Transplantation (ADCT)
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20. Manufacturing of co.don chondrotransplant ® DISC Doc. Doc. Doc. Agreement co.don ® AG Biopsy and Blood obtaining Xmedika Biopsy kit Surgeon Biopsy kit Xmedika new Biopsy kit Shipment via courier, within 48h to co.don® AG
21. Isolation of disc-chondrocytes by enzymatical digestion, monolayer culture, In-Process control Lock in of Biopsy and Serum into the isolator Quality control Manufacturing of co.don chondrotransplant ® DISC Doc. Doc. Doc. Doc. Doc. co.don ® AG Production IIT (Integrated Isolator Technology) Preparation of Biopsy and Serum Receiving control
22. Expansion of disc-chondrocytes in monolayer Manufacturing of co.don chondrotransplant ® DISC Doc. Doc. Doc. Doc. Expansion of disc- chondrocyte transplants If necessary freezing of monolayer cells & recultivation Arrangement of the transplantation appointment between co.don ® AG, Xmedika and surgeon
23. Completion of the product including packing and labeling Quality control Final inspection & Product release Shipment of co.don chondrotransplant ® DISC and under LHO condition u sing an courier organized by co.don ® AG, Xmedika Durability : 43h Manufacturing of co.don chondrotransplant ® DISC Doc. Doc. Doc. Doc. Doc. Doc. Xmedika / Surgeon Transplantation
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