NSF/FDA SIR: Engineered Nanomaterials in Medical Devices: Development of Immune Response Biomarkers

New York University Medical Center, New York NY

Investigators

Abstract

Abstract #1237451 Zelikoff, Judith This proposal, submitted under the NSF/FDA Scholar-in-Residence at FDA Program, seeks to provide mentoring activities for an NYU postdoctoral scholar to conduct scientific research at the FDA (Center for Devices and Radiological Health) on the development/validation of immune response assays useful as early indicators for nanomaterial (NM)-induced toxicity associated with medical device applications. Use of engineered NM for medical devices is rapidly growing. Currently, silver (Ag) nanoparticles (NP) are used for medical device applications(i.e., in wound dressings and catheter coatings) to prevent infections. FDA is also faced with metal oxide NP derived as wear debris from orthopedic implants. Metal-on-metal hip replacement devices made from surgical cobalt-chromium (Co-Cr) alloy, have been shown to release Co and Cr NP by wear mechanisms into the body. Despite clinical assumptions that after the removal of worn hip replacements level of metal ions in the tissue/blood decrease, uncertainty remains about long-term health consequences of these metal particles.