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.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
Primate Research Center Grants (P51)
Project #
Application #
Study Section
Special Emphasis Panel (ZRR1-CM-8 (01))
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Texas Biomedical Research Institute
San Antonio
United States
Zip Code
Mustonen, Allison; Gonzalez, Olga; Mendoza, Elda et al. (2018) Uremic encephalopathy in a rhesus macaque (Macaca mulatta): A case report and a brief review of the veterinary literature. J Med Primatol :
Koistinen, Keith; Mullaney, Lisa; Bell, Todd et al. (2018) Coccidioidomycosis in Nonhuman Primates: Pathologic and Clinical Findings. Vet Pathol 55:905-915
Mahaney, Michael C; Karere, Genesio M; Rainwater, David L et al. (2018) Diet-induced early-stage atherosclerosis in baboons: Lipoproteins, atherogenesis, and arterial compliance. J Med Primatol 47:3-17
Mangosing, Sara; Perminov, Ekaterina; Gonzalez, Olga et al. (2018) Uterine Tumors Resembling Ovarian Sex Cord Tumors in Four Baboons ( Papio spp.). Vet Pathol 55:753-758
Joganic, Jessica L; Willmore, Katherine E; Richtsmeier, Joan T et al. (2018) Additive genetic variation in the craniofacial skeleton of baboons (genus Papio) and its relationship to body and cranial size. Am J Phys Anthropol 165:269-285
Shelton, Elaine L; Waleh, Nahid; Plosa, Erin J et al. (2018) Effects of antenatal betamethasone on preterm human and mouse ductus arteriosus: comparison with baboon data. Pediatr Res 84:458-465
Perminov, Ekaterina; Mangosing, Sara; Confer, Alexandra et al. (2018) A case report of ovotesticular disorder of sex development (OT-DSD) in a baboon (Papio spp.) and a brief review of the non-human primate literature. J Med Primatol 47:192-197
Jensen, Jeffrey T; Hanna, Carol; Mishler, Emily et al. (2018) Effect of menstrual cycle phase and hormonal treatments on evaluation of tubal patency in baboons. J Med Primatol 47:40-45
Confer, Alexandra; Owston, Michael A; Kumar, Shyamesh et al. (2018) Multiple endocrine neoplasia-like syndrome in 24 baboons (Papio spp.). J Med Primatol 47:434-439
Kumar, Shyamesh; Laurence, Hannah; Owston, Michael A et al. (2017) Natural pathology of the captive chimpanzee (Pan troglodytes): A 35-year review. J Med Primatol 46:271-290

Showing the most recent 10 out of 444 publications