The Gene Therapy Primate Core will be located in the Department of Physiology and Medicine at the Southwest Foundation for Biomedical Research in San Antonio, Texas. This core will acquire baboons from the department's resource and timed pregnancy colonies, administer experimental treatments by a variety of routes, maintain baboons that are shedding virus under appropriate containment (biosafety level 2), sample animals regularly to determine the duration of viral shedding, harvest tissues to monitor the success of treatment, necropsy animals to gather materials to measure final endpoints, and prepare and ship samples to Baylor College of Medicine in Houston. The core will provide and maintain premature baboon infants (gestational age = 140 days, term = 185 days) in the Neonatal Intensive Care Unit (NICU), full term newborn infants in the non human primate nursery, and juvenile baboons (24 to 30 months of age) in individual cages in environmentally controlled animal bays. Premature and full term infants will be purchased from the department's breeding colony to produce timed pregnancies and juvenile baboons will be purchased from the department's baboon resource colony. Adenoviral, retroviral, and nonviral vectors will be delivered by tracheal instillation, aerosolization, parenteral injection, or to bronchial arteries by catheterization. Oropharyngeal and rectal swabs will be taken daily to monitor the duration of viral shedding. Serial lung biopsies and lavages will be taken to monitor vector transmission. The left diaphragmatic lobectomy will be performed after virus administration as indicated in experimental design. Premature, full term infant, and juvenile baboons will be necropsied at various times after vector treatment. The core will be directed by K.D. Carey, D.V.M., Ph.D., a laboratory animal veterinarian with more than 15 years experience in maintaining and modeling baboons for cardiovascular and pulmonary research. Tom Dooley, Ph.D., a mammalian molecular biologist with experience in retroviral vector systems, cellular transformation by adenoviruses, and gene cloning and expression studies, will work with Drs. Carey and Seidner to develop working protocols to evaluate risks to professional and technical staff members who handle infected animals, to monitor safety precautions and biocontainment of potential recombinant vectors, and will be available for consultation for prospective studies. Steve Seidner, M.D., a neonatologist in the Department of Pediatrics at the University of Texas Health Science Center, is the Director of Clinical Medicine for the Baboon Neonatal Intensive Care Unit and will supervise biopsy and lavage procedures.
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