Preclinical studies demonstrate neo-generation of corticocancellous bone in critical-sized orthopedic defects using a novel autologous homologous bone construct

C. Garrett, I.V. Estabrooke, G. Yalanis, D. Miller, N. Baetz, P. Labroo, S. Milner, A. Kumar, M. Nahabedian, M. Neumeister, N. Sopko
PolarityTE, Utah, United States

Keywords: Autologous homologous bone construct, orthopedic wound healing, calvarial defects, long bone regeneration, spinal fusion

Autologous bone grafts (ABG) remain the gold-standard for repair of osteopathic defects. Healthy bone is transferred from a donor site, which can result in donor site morbidity, hemorrhage, graft failure, and is limited by harvest amount. Products including demineralized bone matrix (DBM) and exogenous bone morphogenic protein-2 (BMP-2) have failed to regenerate complete corticocancellous bone. An autologous homologous bone construct (AHBC) was developed as a novel therapy to permit small harvest volumes with minimally invasive techniques for the regeneration of functional corticocancellous bone. Skeletally mature New Zealand White rabbits were used to evaluate a series of orthopedic defects. In our cranial study, adjacent defects served as an untreated control and the other defects were treated with either AHBC alone or combined with allogenic dura or allogenic cancellous bone compared to split-calvarial autograft or DBM + BMP2. Digital tomography was performed bi-weekly through study completion at which time harvested bone underwent mechanical testing, genetic profiling, molecular fingerprinting, and histomorphological analysis. Mechanical, compositional, and structural examination demonstrated AHBC-formed bone was similar to ABG, whereas DBM+BMP2 and untreated controls had properties indicative of fibrosis with minimal bone formation. AHBC treatment generated corticocancellous bone with characteristics comparable to native bone in preclinical models.