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Updated: Feb 7, 2026

Introducing Point Mutations into Human Pluripotent Stem Cells Using Seamless Genome Editing
Published on: May 10, 2020
The Human Genome Editing Race: Loosening Regulatory Standards for Commercial Advantage?
Toni Cathomen1, Silke Schüle2, Martina Schüßler-Lenz2
1Institute for Transfusion Medicine and Gene Therapy, Medical Center - University of Freiburg, Freiburg, Germany & Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Abstract:
Medicinal products based on genome editing must undergo rigorous preclinical testing and are subject to regulatory oversight for proper risk assessment prior to first evaluation in humans. We give a European perspective on the regulatory expectations to translate genome editing to the clinic to ensure their timely progress to market.
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