Abstract
stage of the EVPOME for clinical use. A large animal model is also required by the FDA prior to human clinical use; thus we developed a canine EVPOME fabrication protocol that was identical to our human EVPOME protocol. Our canine model enables us to evaluate the fate of EVPOME grafts in situ. Furthermore, the guidelines of CBER require us to demonstrate “dose and potency” of cell-based products, as is seen with drugs. Dose and potency appear to be representative of viable cell numbers and relevant biological function/activity of EVPOME, which provides a quantitative measurement of product quality. These quantitative measurements are challenging and specific for each cell-based product and need to be addressed.
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