Piattaforma chirurgica intelligente per la somministrazione transpeduncolare di terapie rigenerative avanzate nello spazio discale

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1 star t Iisc Piattaforma chirurgica intelligente per la somministrazione transpeduncolare di terapie rigenerative avanzate nello spazio discale Prof. Rocco Papalia Unità di Ricerca di Ortopedia e Traumatologia Facoltà Dipartimentale di Medicina e Chirurgia

2 Regenerative medicine in Orthopaedic Joint and Cartilage Spine Tendon lesions Large bone gap

3 Systematic analysis of the Global Burden of Diseases* Rank Disorders 1. Low back pain 2. Major depressive disorders 3. Iron-deficiency anaemia 4. Neck pain 5. Chronic obstructive pulmonary disease 6. Other musculoskeletal disorders Vos T. et al. The Lancet 2013 *Non fatal health outcomes

4 H 2 O & PG Content Degenerative changes of the IVD Aging Degenerative cascade

5 Degenerative spine disease

6 PG & H 2 0 content Goals of Treatment Therapy regenerate prevent degen. slow down untreated time

7 MSC intradiscal injection Promote proteoglycan production by disc cells stimulation and stem cell differentiation Proteoglycans Nucleus Pulposus Anulus Fibrosus Sobaijma et al. Spine J 2007 Vadalà et al. Spine 2008 Sakai et al, Biomaterials 2006

8 MSCs trasplantation: Fase I study Ten patients with chronic LBP diagnosed with IDD with intact AFwere treated with autologous expanded bone marrow MSC injected into the NP. Orozco et al. 2013

9 In vivo MSC injection for IVD repair to analyze the fate of allogenic MSCs after injection into a stab model of IDD

10 Control Control MRI, X-Ray and Gross Anatomy Weeks Pre-op a b L2-3 c L3-4 L4-5

11 Results: Fluorescent Microscopy Overlapping images Labeled MSCs have been found in osteophytes forming cells

12 MSC may promote osteophyte formation these results suggest that osteophyte formation is a potential side effect of MSC therapy. Future work is needed to optimize the delivery method to make this therapeutic option a clinically viable tool. New surgical approach to the disc

13 Drawbacks of AF route AF tissue is damaged, resulting in the lack of containment of injected cells/hydrogels. Omlor GW, et al. Eur Spine J. 2012; Vadala G, et al. J Tissue Eng Regen Med. 2012; AF needle punctures affect IVD biomechanics, cellularity and biosynthesis, inducing or enhancing a degenerative cascade. Elliott DM, et al. Spine (Phila Pa 1976). 2008; Iatridis JC, et al. Cell Mol Bioeng. 2009; Korecki CL, et al. Spine (Phila Pa 1976). 2008; An increased IDD and disc herniation rate due to AF punctures has been observed in a human study. Carragee EJ, et al. Spine (Phila Pa 1976). 2009; Intradiscal injection procedure is not completely innocuous and may disable regenerative treatments.

14 Cellule Staminali Grants The StemDisc Project: Toward the clinical application Bando PRIN Bando Giovani Ricercatori

15 New directions

16 The transpedicular approach to the human spine Vadalà et al. Spine 2013

17 Transpedicular stem cell injection Transpedicular Approach Nucleotomy MSC injection End-plate sealing with PU

18 MSC transplantation

19 Clinical translation

20 Start-disc project

21 Start-disc project star t Iisc Smart Surgical platform for the Transpedicular delivery of Advanced Regenerative Therapies into the intervertebral DISC space Piattaforma chirurgica intelligente per la somministrazione transpeduncolare di terapie rigenerative avanzate nello spazio discale

22 Research Team RU of Orthopaedic and Traumatology RU of Biomedical Robotics and Biomicrosystems Prof. V. Denaro Prof. R. Papalia Dr. G. Vadalà Prof. E. Guglielmelli Prof. D. Accoto Ing. N. Tagliamonte RU of Neurology Department of Animal Medicine, Production and Health, University of Padua Prof. V. Di Lazzaro Dr. G. Di Pino

23 Project AIMS To develop new surgical tools and technologies for the delivery of the novel regenerative medicine therapies (ATMPs) into the IVD. Specific aims To develop new tools for the delivery of ATMPs to the IVD through the transpedicular approach employing monitoring techniques, and a minimally invasive approach for reproducible, easy, safe and controlled delivery. To select clinical available polymeric biomaterials for closing the transpedicular tunnel (endplate and pedicles) allowing the sealing of the disc space, thus avoiding leakages of ATMPs while maintaining the achieved intradiscal pressure.

24 Start-disc surgical platform

25 Start-disc workflow 1 - Creation of the access to the IVD space 2 - Controlled delivery of ATMPs in the NP 3 - Sealing the endplate by delivery bone cement Monitoring systems: Nerve monitoring system (EMG/ENG) Drilled tissue recognition through mechanical/electrical impedance estimation Monitoring systems: ATMPs volume Intradiscal pressure Monitoring systems: Polymer positioning and volume Intradiscal pressure Fluoroscopic imaging drill components injector Fluoroscopic imaging trocar

26 Workplan

27 Start-disc process Start-disc Project Basic Research Development Testing Engineering Pre-clinical Animal studies Human Clinical studies CE mark Exploitation Regulatory WP1 + WP2 WP3 WP4

28 Transdisc project Innovative tools and technologies for TRANSpedicular delivery of advanced therapies into the intervertebral DISC space for regeneration and repair Second stage under evaluation

29 Consortium

30 Acknowledgments Young researcher involved in the project Dr. F. Russo Ing. S. Valentini Ing. I. Portaccio