title: Surgical technique for spinal cord delivery of therapies: demonstration of procedure in gottingen minipigs.
abstract: This is a compact visual description of a combination of surgical technique and device for the delivery of (gene and cell) therapies into the spinal cord. While the technique is demonstrated in the animal, the procedure is FDA-approved and currently being used for stem cell transplantation into the spinal cords of patients with ALS. While the FDA has recognized proof-of-principle data on therapeutic efficacy in highly characterized rodent models, the use of large animals is considered critical for validating the combination of a surgical procedure, a device, and the safety of a final therapy for human use. The size, anatomy, and general vulnerability of the spine and spinal cord of the swine are recognized to better model the human. Moreover, the surgical process of exposing and manipulating the spinal cord as well as closing the wound in the pig is virtually indistinguishable from the human. We believe that the healthy pig model represents a critical first step in the study of procedural safety.
authors.affiliation: Department of Neurosurgery, Emory University. tfederi@emory.edu
authors.forename: Thais
authors.initials: T
authors.lastname: Federici
authors.forename: Carl V
authors.initials: CV
authors.lastname: Hurtig
authors.forename: Kentrell L
authors.initials: KL
authors.lastname: Burks
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Riley
authors.forename: Vibhor
authors.initials: V
authors.lastname: Krishna
authors.forename: Brandon A
authors.initials: BA
authors.lastname: Miller
authors.forename: Eric A
authors.initials: EA
authors.lastname: Sribnick
authors.forename: Joseph H
authors.initials: JH
authors.lastname: Miller
authors.forename: Natalia
authors.initials: N
authors.lastname: Grin
authors.forename: Jason J
authors.initials: JJ
authors.lastname: Lamanna
authors.forename: Nicholas M
authors.initials: NM
authors.lastname: Boulis
mesh_terms: D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D005260:Female; D015316:Genetic Therapy / Q000379:methods*; D023421:Models, Animal; D013116:Spinal Cord / Q000601:surgery*; D013552:Swine; D013556:Swine, Miniature