Article
Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies.
Stem cells translational medicine - 1 Aug 2016
Barazzetti Gaia, Hurst Samia A, Mauron Alexandre
Abstract excerpt
UNLABELLED: : As research on human embryonic stem cell (hESC)-based therapies is moving from the laboratory to the clinic, there is an urgent need to assess when it can be ethically justified to make the step from preclinical studies to the first protocols involving human subjects. We examined existing regulatory frameworks stating preclinical requirements relevant to the move to first-in-human (FIH) trials and...
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