Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies

• Published in: Stem cells translational medicine Vol. 5; no. 8; pp. 1058 - 1066
• Main Authors: Barazzetti, Gaia, Hurst, Samia A., Mauron, Alexandre
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.08.2016; AlphaMed Press
• Subjects: Benchmarking - ethics; Benchmarking - legislation & jurisprudence; Cell Differentiation; Cell Lineage; Cell Survival; Clinical trials; Clinical Trials as Topic - ethics; Clinical Trials as Topic - legislation & jurisprudence; Embryo cells; Embryonic Stem Cells - transplantation; Ethics; First-in-human trials; Good Manufacturing Practice; Human embryonic stem cells; Human subjects; Humans; Manufacturing; Models, Animal; Movement disorders; Neurodegenerative diseases; Parkinson Disease - diagnosis; Parkinson Disease - surgery; Parkinson's disease; Patient Safety; Pharmaceuticals; Phenotype; Policy Making; Preclinical benchmarks; Principles; Quality; Research Design - legislation & jurisprudence; Research ethics; Risk Assessment; Standards, Policies, Protocols, and Regulations for Cell-Based Therapies; Stem Cell Transplantation - adverse effects; Stem Cell Transplantation - ethics; Stem Cell Transplantation - legislation & jurisprudence; Stem Cell Transplantation - methods; Stem cells; Translational research; Translational Research, Biomedical - ethics; Translational Research, Biomedical - legislation & jurisprudence; United States > US; Europe; Human embryonic stem cells; Preclinical benchmarks; First-in-human trials; Research ethics; Translational research

: 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 regulato...