Human genome editing in the clinic: new challenges in regulatory benefit-risk assessment
Open accessAbstract
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.
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In murine studies, CAR T cells cultured for only 3 days exhibited superior antitumor activity at a 6-fold lower dose compared to CAR T cells harvested after a longer culture period.
“Murine studies revealed that CAR T cells cultured for only 3 days exhibited superior antitumor activity at a much lower dose (6-fold lower) compared to CAR T cells harvested after a longer culture period (114).”
From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [114]
The passages on CAR T cells (Abstract; page unavailable) discuss clinical genome-editing applications, not murine comparisons of culture duration or antitumor activity. Searches for three-day culture, a six-fold lower dose, and murine antitumor activity found no passage addressing the claim. (LLM, conf=0.73)
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References 10 · Cited by 31
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Research works printed but not linked: 8
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- Authors
- Abou-El-Enein, M., Cathomen, T., Ivics, Z., June, C. H., Renner, M., Schneider, C. K., & Bauer, G.
- Affiliations
- University of Freiburg (DE)
- Paul Ehrlich Institut (DE)
- University of Pennsylvania (US)
- Medicines and Healthcare products Regulatory Agency (GB)
- University of California, Davis (US)
- Venue
- Cell Stem Cell
- Publisher
- Elsevier BV
- Published
- 2017-10
- Volume
- 21
- Issue
- 4
- Pages
- 427-430
- ISSN
- 1875-9777 (ISSN-L)
- 1934-5909
- OpenAlex
- W2764322055
- Cited by
- 31
- References
- 10
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2023: 2 · 2022: 4 · 2021: 6 · 2020: 5 · 2019: 4 · 2018: 6
- FWCI
- 1.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Cell stem cell (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › CRISPR and Genetic Engineering
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- human genome editing, risk-benefit assessment, regulatory framework, gene therapy regulation, safety assessment, efficacy evaluation, CRISPR/Cas9
- MeSH terms
- Gene Editing, Clinical Trials as Topic, Feasibility Studies, Humans, Social Control, Formal, Genome, Human, Risk Assessment, CRISPR-Cas Systems
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