Balancing safety and innovation for cell-based regenerative medicine
Abstract
FDA’s Track for Cell-Based Therapies Added to several other tracks to speed development of therapeutic agents that are safe and effective, the FDA has created a new regulatory pathway for cell-based therapies in regenerative medicine.
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The fusion between reverse transcriptase and catalytically impaired Cas9 endonuclease might enable delivery of gene cassettes without double-strand breaks, which induces much lower off-target editing.
“The emergence of new tools such as the fusion between reverse transcriptase and catalytically impaired Cas9 endonuclease might enable the delivery of gene cassettes without the need for double-strand breaks (DSB) which also induces much lower off-target editing (147).”
From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [147]
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References 7 · Cited by 173
- Authors
- Marks, P., & Gottlieb, S.
- Affiliations
- United States Food and Drug Administration (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-03-08
- Volume
- 378
- Issue
- 10
- Pages
- 954-959
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2791961560
- Cited by
- 173
- References
- 7
- Citations by year
- 2026: 26 · 2025: 13 · 2024: 13 · 2023: 16 · 2022: 18 · 2021: 26 · 2020: 21 · 2019: 21 · 2018: 19
- FWCI
- 14.91
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
- Keywords
- cell therapy, regenerative medicine, FDA regulatory pathways, drug development, safety, innovation, regulatory approval
- MeSH terms
- Biological Products, Consumer Product Safety, Humans, United States, United States Food and Drug Administration, Hematopoietic Stem Cell Transplantation, Government Regulation, Regenerative Medicine, Cell- and Tissue-Based Therapy
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