title: Spinal cord injury clinical trials translational process, review of past and proposed acute trials with reference to recommended trial guidelines.
abstract: Within the past few years there has been increasing interest in the translation of experimental therapeutic interventions to improve functional outcomes after spinal cord injury (SCI). The number of reported successes using preclinical animal models has been substantial and this has encouraged the development of several clinical trial programs. We will briefly discuss a desired process for the translation of preclinical therapeutic discoveries, as well as the design and conduct of valid human SCI studies. Past SCI trials are examined and current ongoing human studies are outlined. We identify some of the confounding factors that can influence the accurate interpretation of study outcomes. The discussion here will be restricted to treatment strategies that involve drug administration and cell transplants, not that these are currently the most beneficial treatments, but cell transplants are already being offered to patients without completing a valid clinical trial program.
authors.affiliation: University of British Columbia, Vancouver, Canada. steeves@icord.org
authors.forename: John
authors.initials: J
authors.lastname: Steeves
authors.forename: Andrew
authors.initials: A
authors.lastname: Blight
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D006801:Humans; D012107:Research Design / Q000592:standards*; D013119:Spinal Cord Injuries / Q000628:therapy*