title: Target populations for first-in-human embryonic stem cell research in spinal cord injury.
abstract: Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial.
authors.affiliation: Department of Anatomy and Neurobiology, Dalhousie University, Halifax, Nova Scotia B3H 3J5, Canada. frederic.bretzner@dal.ca
authors.forename: Frédéric
authors.initials: F
authors.lastname: Bretzner
authors.forename: Frédéric
authors.initials: F
authors.lastname: Gilbert
authors.forename: Françoise
authors.initials: F
authors.lastname: Baylis
authors.forename: Robert M
authors.initials: RM
authors.lastname: Brownstone
mesh_terms: D001709:Biotechnology / Q000941:ethics / Q000639:trends; D017321:Clinical Trials, Phase I as Topic; D003362:Cost-Benefit Analysis; D053595:Embryonic Stem Cells / Q000637:transplantation*; D006801:Humans; D009103:Multiple Sclerosis / Q000453:epidemiology / Q000628:therapy*; D028701:Patient Rights; D018579:Patient Selection / Q000941:ethics*; D020379:Risk Adjustment; D013119:Spinal Cord Injuries / Q000191:economics / Q000453:epidemiology / Q000628:therapy*; D057905:Stem Cell Research; D033581:Stem Cell Transplantation