Does xenogeneic demineralized bone matrix have clinical utility as a bone graft substitute?

Autologous bone harvested from the iliac crest is a commonly used grafting material for a number of surgical procedures; however, there is documented morbidity associated with secondary site harvesting. Because demineralized bone matrix (DBM) is inherently osteoinductive (i.e., it facilitates differentiation of uncommitted connective tissue cells into bone-forming cells), it has potential appeal as a bone-graft substitute. Allogeneic DBM usage has intrinsic shortcomings related to procuring, processing and characterizing bone from a human donor pool. Xenogeneic bone represents an unlimited supply of available material if it can be processed to render it safe for transplantation to the human host. It is hypothesized that reported immunogenicity and non-viability of xenogeneic DBM results from lipids and plasma proteins not removed during typical demineralization processes. The authors propose a rigorous examination of this hypothesis, followed by several pivotal studies to determine the effectiveness of xenogeneic DBM.