Demineralized bone matrix as an osteoinductive biomaterial and in vitro predictors of its biological potential.

The osteoinductivity of demineralized bone matrix (DBM) varies from donor to donor as a result of varying levels of multiple growth factors, matrix integrity, and artifacts from material processing. Many in vitro assays are currently used for screening the osteoinductivity of DBM. The objectives of this study were to determine the correlation of specific growth factors and in vitro mitotic stimulation to in vivo ectopic bone formation capacity with a large number of DBM samples. Samples were assayed using ELISA methods for BMP-2/4 and TGF-beta1 (n = 304) and cell proliferation using SAOS-2 osteoblasts (n = 239). All samples were then implanted intramuscularly in the abdomen of nude rats. All in vitro assays showed significant variability for any particular level of ostoinductivity determined by in vivo model. A significant, but only very weak, positive correlation to in vivo results was found for TGF-beta1 (r(2) = 0.016), BMP 2/4 (r(2) = 0.065), and SAOS-2 cell proliferation (r(2) = 0.053). The results of this study amplify the notion that a multitude of factors and their relative interplay, rather than a single factor are likely to determine the potency of any particular lot of DBM.