Bone graft substitutes have been developed due to the limited supply and morbidity associated with using autogenous graft material. Allogeneic demineralized bone matrix (DBM) has been used extensively as a clinical graft material because of its inherent osteoinductive and osteoconductive properties. Differential enhancement of these properties may optimize the performance of these products for various orthopedic and craniofacial applications. Commercially available bone paste products consist of formulations that combine DBM with a carrier to facilitate handling and containment. In the present study, we present results of a comprehensive in vitro and in vivo characterization of a 100% human DBM putty product, Puros DBM Putty. Results indicate the DBM particles are completely dispersed in the putty. Data are presented showing the porosity of and cell attachment to Puros DBM Putty, thereby demonstrating the osteoconductive properties of this DBM. Puros DBM Putty was also shown to be osteoinductive in the rat ectopic pouch model. We demonstrate here for the first time that Puros DBM Putty maintains its activity to markedly stimulate or induce bone formation over the entire period of its shelf life. Taken together, these data demonstrate that the 100% human allograft derived Puros DBM Putty could be an effective bone graft substitute.
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