Evaluation of the efficacy of a novel RIA/mPCL-TCP Scaffold System in repairing critical-sized segmental bone defects compared to the gold standard autograft treatment in an ovine large animal model

• Applicant: Dr. Jan Henkel
• Subject Area: Orthopaedics, Traumatology, Reconstructive Surgery ; Biomaterials ; Synthesis and Properties of Functional Materials
• Term: from 2013 to 2015
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 249847580

• Final Report Year: 2015

Final Report Abstract

Using fused deposition modeling, cylindrical mPCL-TCP scaffolds with central fenestrations were created. Scaffold features comprised 70% porosity, fully interconnected pores, forming a 0/90° lay-down pattern. A 6 cm defect was created in 22 sheep tibiae according to protocols published by our study group. The (critical sized) bone defects were then treated with either RIA alone, mPCL-TCP scaffold with RIA, or ICBG alone. The study spanned a 3- and 12-month time point interval. Bone formation and mechanical properties were evaluated through x-rays, Micro-computed tomography (µCT), biomechanical testing, scanning electron microscopy (SEM), backscattered electron microscopy (BSE), second harmonic generation (SHG), immunohistochemical and histological analyses. The multimodal histological and immunohistochemical outcomes indicate that even after 12-months of implantation, RIA fragments continue to demonstrate osteoconductive properties. Furthermore, when integrated with mPCL-TCP scaffolds, they not only retained their structural integrity but scaffolds also prevented graft resorption, thereby enhancing bone formation. Further studies will be necessary to translate this promising approach from bench to bedside.

Publications

• Bone Regeneration based on Tissue Engineering Conceptions – A 21st Century Perspective. Bone Research (2013) 3: 216-248
  J. Henkel, M. Woodruff, D.R. Epari, R. Steck, V. Glatt, I.C. Dickson, P.F. Choong, M.A. Schuetz, D.W. Hutmacher
  
• Design and fabrication of scaffold-based tissue engineering. BioNanoMaterials, Volume 14, Issue 3-4, Pages 171–193, ISSN (Online) 2193-066X, ISSN (Print) 2193-0651, December 2013
  J. Henkel, D.W. Hutmacher
  
• Delayed Minimally Invasive Injection of Allogenic Bone Marrow Stromal Cell Sheets Regenerates Large Bone Defects in an Ovine Preclinical Animal Model. Stem Cells Transl Med. 2015 May;4(5):503-12. Epub 2015 April
  Berner A, Henkel J, Woodruff MA, Steck R, Nerlich M, Schuetz MA, Hutmacher DW
  (See online at https://doi.org/10.5966/sctm.2014-0244)