title: Unintended changes in cognition, mood, and behavior arising from cell-based interventions for neurological conditions: ethical challenges.
abstract: The prospect of using cell-based interventions (CBIs) to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior-brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment.
authors.affiliation: Johns Hopkins University, Baltimore, MD 21205, USA.
authors.forename: P S
authors.initials: PS
authors.lastname: Duggan
authors.forename: A W
authors.initials: AW
authors.lastname: Siegel
authors.forename: D M
authors.initials: DM
authors.lastname: Blass
authors.forename: H
authors.initials: H
authors.lastname: Bok
authors.forename: J T
authors.initials: JT
authors.lastname: Coyle
authors.forename: R
authors.initials: R
authors.lastname: Faden
authors.forename: J
authors.initials: J
authors.lastname: Finkel
authors.forename: J D
authors.initials: JD
authors.lastname: Gearhart
authors.forename: H T
authors.initials: HT
authors.lastname: Greely
authors.forename: A
authors.initials: A
authors.lastname: Hillis
authors.forename: A
authors.initials: A
authors.lastname: Hoke
authors.forename: R
authors.initials: R
authors.lastname: Johnson
authors.forename: M
authors.initials: M
authors.lastname: Johnston
authors.forename: J
authors.initials: J
authors.lastname: Kahn
authors.forename: D
authors.initials: D
authors.lastname: Kerr
authors.forename: P
authors.initials: P
authors.lastname: King
authors.forename: J
authors.initials: J
authors.lastname: Kurtzberg
authors.forename: S M
authors.initials: SM
authors.lastname: Liao
authors.forename: J W
authors.initials: JW
authors.lastname: McDonald
authors.forename: G
authors.initials: G
authors.lastname: McKhann
authors.forename: K B
authors.initials: KB
authors.lastname: Nelson
authors.forename: M
authors.initials: M
authors.lastname: Rao
authors.forename: A
authors.initials: A
authors.lastname: Regenberg
authors.forename: K
authors.initials: K
authors.lastname: Smith
authors.forename: D
authors.initials: D
authors.lastname: Solter
authors.forename: H
authors.initials: H
authors.lastname: Song
authors.forename: J
authors.initials: J
authors.lastname: Sugarman
authors.forename: R J
authors.initials: RJ
authors.lastname: Traystman
authors.forename: A
authors.initials: A
authors.lastname: Vescovi
authors.forename: J
authors.initials: J
authors.lastname: Yanofski
authors.forename: W
authors.initials: W
authors.lastname: Young
authors.forename: D J H
authors.initials: DJ
authors.lastname: Mathews
mesh_terms: D000339:Affect; D001519:Behavior; D035843:Biomedical Research / Q000941:ethics; D016380:Brain Tissue Transplantation / Q000009:adverse effects / Q000941:ethics*; D017690:Cell Transplantation / Q000009:adverse effects / Q000941:ethics*; D002493:Central Nervous System Diseases / Q000601:surgery*; D002986:Clinical Trials as Topic / Q000941:ethics*; D003071:Cognition; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent; D009483:Neuropsychological Tests; D035842:Research Subjects; D011795:Surveys and Questionnaires; D036302:Therapeutic Human Experimentation / Q000941:ethics