Open AccessAdapting Preclinical Benchmarks for First‐in‐Human Trials of Human Embryonic Stem Cell‐Based Therapies
Author(s) -
Barazzetti Gaia,
Hurst Samia A.,
Mauron Alexandre
Publication year - 2016
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.5966/sctm.2015-0222
Subject(s) - context (archaeology) , translational research , embryonic stem cell , translational medicine , clinical trial , psychological intervention , medicine , risk analysis (engineering) , human studies , preclinical research , bioinformatics , computer science , biology , medical physics , pathology , paleontology , biochemistry , psychiatry , gene
Relevant preclinical benchmarks require rethinking (i.e., identity and purity) or need to be adjusted (i.e., potency and viability) to anticipate safety and efficacy concerns related to the dynamic heterogeneity of human embryonic stem cells (hESCs).This article reviews existing regulatory frameworks for preclinical requirements of first‐in‐human trials and assesses how their underlying principles may best be applied in the context of hESC‐based interventions for treatment of Parkinson's disease.