This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The purpose of this study is to evaluate the safety and efficacy of injecting a growth factor protein known as GEM-OS2' which is the product name for a platelet-derived growth factor-BB (rhPDGF-BB) mixed with a collagen/P-tricalcium phosphate paste (P-TCP), into the vertebral bodies of baboons. It is expected that injection of this material into the spine of the baboons will prove to be safe, that is, free of any adverse outcomes or toxicity relating to the nervous and bone tissues. In addition, it is expected that injection of rhPDGF-BB combined with a collagen@-TCP matrix into the vertebral bodies with IV administration of a bisphosphonate, which prevents bone resorption, will lead to a statistically significant increase in the density of the treated bones ( or = to 5% increase). The animals will be observed regularly following treatment for any changes in behaviour or ability to move normally. Non-invasive imaging techniques (for example, x-ray radiographs, magnetic resonance imaging (MRI)) will be used to monitor the structure of the treated vertebral bones and surrounding soft tissues to ensure that no abnormal tissue growth occurs following the treatments. Additional imaging techniques (dual-energy x-ray absorptiometry (DEXA) and quantitative computed-tomography (qCT)) used for measuring the amount of bone formed will be employed to evaluate the efficacy of the treatments in increasing bone density in the aged baboons, similarly to what would be performed for a human patient. Molecules in serum indicative of normal bone metabolism will be monitored to ensure no abnormal changes in metabolism occur as a result of the injections.Osteoporosis is a condition in which human patients experience a significant loss of bone mineral density over time, and leads to painful and debilitating compression fractures of the vertebral bodies of the spine. With an ever-increasing geriatric population in the United States, there is a great need for therapies that will treat or reverse the effects of osteoporosis. The GEM-OS2TM product is intended for injection into the vertebral bodies where we expect it will lead to augmentation of the bone in this location and reduce the number of fractures experienced by osteoporosis patients. The testing of GEM OS2TM in the baboon model will demonstrate that it can be administered safely, and demonstrate its efficacy in augmenting bone mineral density following treatment with the material. The success of this study will lead to clinical trial testing for the product in osteoporotic human patients.
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