Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment

Mohamed Abou-El-Enein, Toni Cathomen, Zoltán Ivics, Carl H. June, Matthias Renner, Christian K. Schneider, Gerhard Bauer

Research output: Contribution to journalComment/debate

10 Scopus citations

Abstract

As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues.

Original languageEnglish (US)
Pages (from-to)427-430
Number of pages4
JournalCell Stem Cell
Volume21
Issue number4
DOIs
StatePublished - Oct 5 2017

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Keywords

  • benefit-risk assessment
  • clinical trials
  • efficacy
  • genome editing
  • off-target effects
  • regulations
  • safety

ASJC Scopus subject areas

  • Molecular Medicine
  • Genetics
  • Cell Biology

Cite this

Abou-El-Enein, M., Cathomen, T., Ivics, Z., June, C. H., Renner, M., Schneider, C. K., & Bauer, G. (2017). Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment. Cell Stem Cell, 21(4), 427-430. https://doi.org/10.1016/j.stem.2017.09.007