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 Citations (Scopus)

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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Human Genome
Technology
Safety
Gene Editing

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

Human Genome Editing in the Clinic : New Challenges in Regulatory Benefit-Risk Assessment. / Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H.; Renner, Matthias; Schneider, Christian K.; Bauer, Gerhard.

In: Cell Stem Cell, Vol. 21, No. 4, 05.10.2017, p. 427-430.

Research output: Contribution to journalComment/debate

Abou-El-Enein, M, Cathomen, T, Ivics, Z, June, CH, Renner, M, Schneider, CK & Bauer, G 2017, 'Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment', Cell Stem Cell, vol. 21, no. 4, pp. 427-430. https://doi.org/10.1016/j.stem.2017.09.007
Abou-El-Enein M, Cathomen T, Ivics Z, June CH, Renner M, Schneider CK et al. Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment. Cell Stem Cell. 2017 Oct 5;21(4):427-430. https://doi.org/10.1016/j.stem.2017.09.007
Abou-El-Enein, Mohamed ; Cathomen, Toni ; Ivics, Zoltán ; June, Carl H. ; Renner, Matthias ; Schneider, Christian K. ; Bauer, Gerhard. / Human Genome Editing in the Clinic : New Challenges in Regulatory Benefit-Risk Assessment. In: Cell Stem Cell. 2017 ; Vol. 21, No. 4. pp. 427-430.
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