Genotoxic effects of base and prime editing in human hematopoietic stem cells.


Journal

Nature biotechnology
ISSN: 1546-1696
Titre abrégé: Nat Biotechnol
Pays: United States
ID NLM: 9604648

Informations de publication

Date de publication:
07 Sep 2023
Historique:
received: 21 11 2022
accepted: 26 07 2023
medline: 8 9 2023
pubmed: 8 9 2023
entrez: 7 9 2023
Statut: aheadofprint

Résumé

Base and prime editors (BEs and PEs) may provide more precise genetic engineering than nuclease-based approaches because they bypass the dependence on DNA double-strand breaks. However, little is known about their cellular responses and genotoxicity. Here, we compared state-of-the-art BEs and PEs and Cas9 in human hematopoietic stem and progenitor cells with respect to editing efficiency, cytotoxicity, transcriptomic changes and on-target and genome-wide genotoxicity. BEs and PEs induced detrimental transcriptional responses that reduced editing efficiency and hematopoietic repopulation in xenotransplants and also generated DNA double-strand breaks and genotoxic byproducts, including deletions and translocations, at a lower frequency than Cas9. These effects were strongest for cytidine BEs due to suboptimal inhibition of base excision repair and were mitigated by tailoring delivery timing and editor expression through optimized mRNA design. However, BEs altered the mutational landscape of hematopoietic stem and progenitor cells across the genome by increasing the load and relative proportions of nucleotide variants. These findings raise concerns about the genotoxicity of BEs and PEs and warrant further investigation in view of their clinical application.

Identifiants

pubmed: 37679541
doi: 10.1038/s41587-023-01915-4
pii: 10.1038/s41587-023-01915-4
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Fondazione Telethon (Telethon Foundation)
ID : Core grant
Organisme : EC | Horizon 2020 Framework Programme (EU Framework Programme for Research and Innovation H2020)
ID : UPGRADE
Organisme : EC | Horizon 2020 Framework Programme (EU Framework Programme for Research and Innovation H2020)
ID : X-PAND
Organisme : European Hematology Association (EHA)
ID : 2022 Junior Research Grant
Organisme : EC | EU Framework Programme for Research and Innovation H2020 | H2020 Priority Excellent Science | H2020 Marie Sklodowska-Curie Actions (H2020 Excellent Science - Marie Sklodowska-Curie Actions)
ID : 101031856

Informations de copyright

© 2023. The Author(s).

Références

Naldini, L. Genetic engineering of hematopoiesis: current stage of clinical translation and future perspectives. EMBO Mol. Med. 11, e9958 (2019).
pubmed: 30670463 pmcid: 6404113 doi: 10.15252/emmm.201809958
Doudna, J. A. The promise and challenge of therapeutic genome editing. Nature 578, 229–236 (2020).
pubmed: 32051598 pmcid: 8992613 doi: 10.1038/s41586-020-1978-5
Ferrari, S. et al. Genetic engineering meets hematopoietic stem cell biology for next-generation gene therapy. Cell Stem Cell 30, 549–570 (2023).
pubmed: 37146580 doi: 10.1016/j.stem.2023.04.014
Porteus, M. H. A new class of medicines through DNA editing. N. Engl. J. Med. 380, 947–959 (2019).
pubmed: 30855744 doi: 10.1056/NEJMra1800729
Schiroli, G. et al. Precise gene editing preserves hematopoietic stem cell function following transient p53-mediated DNA damage response. Cell Stem Cell 24, 551–565 (2019).
pubmed: 30905619 pmcid: 6458988 doi: 10.1016/j.stem.2019.02.019
Ferrari, S. et al. Efficient gene editing of human long-term hematopoietic stem cells validated by clonal tracking. Nat. Biotechnol. 38, 1298–1308 (2020).
pubmed: 32601433 pmcid: 7610558 doi: 10.1038/s41587-020-0551-y
Adikusuma, F. et al. Large deletions induced by Cas9 cleavage. Nature 560, E8–E9 (2018).
pubmed: 30089922 doi: 10.1038/s41586-018-0380-z
Leibowitz, M. L. et al. Chromothripsis as an on-target consequence of CRISPR–Cas9 genome editing. Nat. Genet. 53, 895–905 (2021).
pubmed: 33846636 pmcid: 8192433 doi: 10.1038/s41588-021-00838-7
Park, S. H. et al. Comprehensive analysis and accurate quantification of unintended large gene modifications induced by CRISPR–Cas9 gene editing. Sci. Adv. 8, eabo7676 (2022).
pubmed: 36269834 pmcid: 9586483 doi: 10.1126/sciadv.abo7676
Turchiano, G. et al. Quantitative evaluation of chromosomal rearrangements in gene-edited human stem cells by CAST-seq. Cell Stem Cell 28, 1136–1147 (2021).
pubmed: 33626327 doi: 10.1016/j.stem.2021.02.002
Kosicki, M., Tomberg, K. & Bradley, A. Repair of double-strand breaks induced by CRISPR-Cas9 leads to large deletions and complex rearrangements. Nat. Biotechnol. 36, 765–771 (2018).
pubmed: 30010673 pmcid: 6390938 doi: 10.1038/nbt.4192
Takata, M. et al. Homologous recombination and non-homologous end-joining pathways of DNA double-strand break repair have overlapping roles in the maintenance of chromosomal integrity in vertebrate cells. EMBO J. 17, 5497–5508 (1998).
pubmed: 9736627 pmcid: 1170875 doi: 10.1093/emboj/17.18.5497
Anzalone, A. V., Koblan, L. W. & Liu, D. R. Genome editing with CRISPR–Cas nucleases, base editors, transposases and prime editors. Nat. Biotechnol. 38, 824–844 (2020).
pubmed: 32572269 doi: 10.1038/s41587-020-0561-9
Ferrari, S. et al. Choice of template delivery mitigates the genotoxic risk and adverse impact of editing in human hematopoietic stem cells. Cell Stem Cell 29, 1428–1444 (2022).
pubmed: 36206730 pmcid: 9550218 doi: 10.1016/j.stem.2022.09.001
Rees, H. A. & Liu, D. R. Base editing: precision chemistry on the genome and transcriptome of living cells. Nat. Rev. Genet. 19, 770–788 (2018).
pubmed: 30323312 pmcid: 6535181 doi: 10.1038/s41576-018-0059-1
Komor, A. C., Kim, Y. B., Packer, M. S., Zuris, J. A. & Liu, D. R. Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage. Nature 533, 420–424 (2016).
pubmed: 27096365 pmcid: 4873371 doi: 10.1038/nature17946
Antoniou, P., Miccio, A. & Brusson, M. Base and prime editing technologies for blood disorders. Front. Genome Ed. 3, 618406 (2021).
pubmed: 34713251 pmcid: 8525391 doi: 10.3389/fgeed.2021.618406
Wang, L. et al. Reactivation of γ-globin expression through Cas9 or base editor to treat β-hemoglobinopathies. Cell Res. 30, 276–278 (2020).
pubmed: 31911671 pmcid: 7054297 doi: 10.1038/s41422-019-0267-z
Zeng, J. et al. Therapeutic base editing of human hematopoietic stem cells. Nat. Med. 26, 535–541 (2020).
pubmed: 32284612 pmcid: 7869435 doi: 10.1038/s41591-020-0790-y
Gaudelli, N. M. et al. Directed evolution of adenine base editors with increased activity and therapeutic application. Nat. Biotechnol. 38, 892–900 (2020).
pubmed: 32284586 doi: 10.1038/s41587-020-0491-6
Newby, G. A. et al. Base editing of haematopoietic stem cells rescues sickle cell disease in mice. Nature 595, 295–302 (2021).
pubmed: 34079130 pmcid: 8266759 doi: 10.1038/s41586-021-03609-w
Anzalone, A. V. et al. Search-and-replace genome editing without double-strand breaks or donor DNA. Nature 576, 149–157 (2019).
pubmed: 31634902 pmcid: 6907074 doi: 10.1038/s41586-019-1711-4
Petri, K. et al. CRISPR prime editing with ribonucleoprotein complexes in zebrafish and primary human cells. Nat. Biotechnol. 40, 189–193 (2022).
pubmed: 33927418 doi: 10.1038/s41587-021-00901-y
Chen, P. J. et al. Enhanced prime editing systems by manipulating cellular determinants of editing outcomes. Cell 184, 5635–5652 (2021).
pubmed: 34653350 pmcid: 8584034 doi: 10.1016/j.cell.2021.09.018
Everette, K. A. et al. Ex vivo prime editing of patient haematopoietic stem cells rescues sickle-cell disease phenotypes after engraftment in mice. Nat. Biomed. Eng. 7, 616–628 (2023).
Nelson, J. W. et al. Engineered pegRNAs improve prime editing efficiency. Nat. Biotechnol. 40, 402–410 (2021).
pubmed: 34608327 pmcid: 8930418 doi: 10.1038/s41587-021-01039-7
Koblan, L. W. et al. Improving cytidine and adenine base editors by expression optimization and ancestral reconstruction. Nat. Biotechnol. 36, 843–846 (2018).
pubmed: 29813047 pmcid: 6126947 doi: 10.1038/nbt.4172
Kurt, I. C. et al. CRISPR C-to-G base editors for inducing targeted DNA transversions in human cells. Nat. Biotechnol. 39, 41–46 (2021).
pubmed: 32690971 doi: 10.1038/s41587-020-0609-x
Bai, T. et al. Expansion of primitive human hematopoietic stem cells by culture in a zwitterionic hydrogel. Nat. Med. 25, 1566–1575 (2019).
pubmed: 31591594 doi: 10.1038/s41591-019-0601-5
Scala, S. et al. Dynamics of genetically engineered hematopoietic stem and progenitor cells after autologous transplantation in humans. Nat. Med. 24, 1683–1690 (2018).
pubmed: 30275570 doi: 10.1038/s41591-018-0195-3
Ferreira da Silva, J. et al. Prime editing efficiency and fidelity are enhanced in the absence of mismatch repair. Nat. Commun. 13, 760 (2022).
pubmed: 35140211 pmcid: 8828784 doi: 10.1038/s41467-022-28442-1
Neugebauer, M. E. et al. Evolution of an adenine base editor into a small, efficient cytosine base editor with low off-target activity. Nat. Biotechnol. 41, 673–685 (2023).
Lam, D. K. et al. Improved cytosine base editors generated from TadA variants. Nat. Biotechnol. 41, 686–697 (2023).
Al-Bahlani, S. et al. P73 regulates cisplatin-induced apoptosis in ovarian cancer cells via a calcium/calpain-dependent mechanism. Oncogene 30, 4219–4230 (2011).
pubmed: 21516125 pmcid: 3194400 doi: 10.1038/onc.2011.134
Long, S. L., Morales, J. C., Hwang, A., Wagner, M. W. & Boothman, D. A. DNA mismatch repair-dependent activation of c-Abl/p73α/GADD45α-mediated apoptosis. J. Biol. Chem. 283, 21394–21403 (2008).
doi: 10.1074/jbc.M709954200
Kuzminov, A. Single-strand interruptions in replicating chromosomes cause double-strand breaks. Proc. Natl Acad. Sci. USA 98, 8241–8246 (2001).
pubmed: 11459959 pmcid: 37427 doi: 10.1073/pnas.131009198
Beerman, I., Seita, J., Inlay, M. A., Weissman, I. L. & Rossi, D. J. Quiescent hematopoietic stem cells accumulate DNA damage during aging that is repaired upon entry into cell cycle. Cell Stem Cell 15, 37–50 (2014).
pubmed: 24813857 pmcid: 4082747 doi: 10.1016/j.stem.2014.04.016
Canarutto, D. et al. Peripheral blood stem and progenitor cell collection in pediatric candidates for ex vivo gene therapy: a 10-year series. Mol. Ther. Methods Clin. Dev. 22, 76–83 (2021).
pubmed: 34485596 pmcid: 8390560 doi: 10.1016/j.omtm.2021.05.013
Amabile, A. et al. Inheritable silencing of endogenous genes by hit-and-run targeted epigenetic editing. Cell 167, 219–232 (2016).
pubmed: 27662090 pmcid: 5039111 doi: 10.1016/j.cell.2016.09.006
Nuñez, J. K. et al. Genome-wide programmable transcriptional memory by CRISPR-based epigenome editing. Cell 184, 2503–2519 (2021).
pubmed: 33838111 pmcid: 8376083 doi: 10.1016/j.cell.2021.03.025
Hsu, J. Y. et al. PrimeDesign software for rapid and simplified design of prime editing guide RNAs. Nat. Commun. 12, 1034 (2021).
pubmed: 33589617 pmcid: 7884779 doi: 10.1038/s41467-021-21337-7
Mathis, N. et al. Predicting prime editing efficiency and product purity by deep learning. Nat. Biotechnol. 41, 1151–1159 (2023).
pubmed: 36646933 doi: 10.1038/s41587-022-01613-7
Li, G. M. The role of mismatch repair in DNA damage-induced apoptosis. Oncol. Res. 11, 393–400 (1999).
pubmed: 10821533
Sobol, R. W. et al. Mutations associated with base excision repair deficiency and methylation-induced genotoxic stress. Proc. Natl Acad. Sci. USA 99, 6860–6865 (2002).
pubmed: 11983862 pmcid: 124494 doi: 10.1073/pnas.092662499
Schanz, S., Castor, D., Fischer, F. & Jiricny, J. Interference of mismatch and base excision repair during the processing of adjacent U/G mispairs may play a key role in somatic hypermutation. Proc. Natl Acad. Sci. USA 106, 5593–5598 (2009).
pubmed: 19307563 pmcid: 2659717 doi: 10.1073/pnas.0901726106
Omer-Javed, A. et al. Mobilization-based chemotherapy-free engraftment of gene-edited human hematopoietic stem cells. Cell 185, 2248–2264 (2022).
pubmed: 35617958 pmcid: 9240327 doi: 10.1016/j.cell.2022.04.039
Chow, R. D., Chen, J. S., Shen, J. & Chen, S. A web tool for the design of prime-editing guide RNAs. Nat. Biomed. Eng. 5, 190–194 (2020).
pubmed: 32989284 pmcid: 7882013 doi: 10.1038/s41551-020-00622-8
Kluesner, M. G. et al. EditR: a method to quantify base editing from Sanger sequencing. CRISPR J. 1, 239–250 (2018).
pubmed: 31021262 pmcid: 6694769 doi: 10.1089/crispr.2018.0014
Brinkman, E. K., Chen, T., Amendola, M. & Van Steensel, B. Easy quantitative assessment of genome editing by sequence trace decomposition. Nucleic Acids Res. 42, e168 (2014).
pubmed: 25300484 pmcid: 4267669 doi: 10.1093/nar/gku936
Soldi, M. et al. Laboratory-scale lentiviral vector production and purification for enhanced ex vivo and in vivo genetic engineering. Mol. Ther. Methods Clin. Dev. 19, 411–425 (2020).
pubmed: 33294490 pmcid: 7683235 doi: 10.1016/j.omtm.2020.10.009
Clement, K. et al. Accurate and rapid analysis of genome editing data from nucleases and base editors with CRISPResso2. Nat. Biotechnol. 37, 224–226 (2019).
pubmed: 30809026 pmcid: 6533916 doi: 10.1038/s41587-019-0032-3
Ferrari, S. et al. BAR-seq clonal tracking of gene-edited cells. Nat. Protoc. 16, 2991–3025 (2021).
pubmed: 34031609 doi: 10.1038/s41596-021-00529-x
Li, J. et al. Structure-guided engineering of adenine base editor with minimized RNA off-targeting activity. Nat. Commun. 12, 2287 (2021).
pubmed: 33863894 pmcid: 8052359 doi: 10.1038/s41467-021-22519-z
Rees, H. A., Wilson, C., Doman, J. L. & Liu, D. R. Analysis and minimization of cellular RNA editing by DNA adenine base editors. Sci. Adv. 5, 294–310 (2019).
doi: 10.1126/sciadv.aax5717
Ahdesmäki, M. J., Gray, S. R., Johnson, J. H. & Lai, Z. Disambiguate: an open-source application for disambiguating two species in next generation sequencing data from grafted samples. F1000Res 5, 2741 (2016).
pubmed: 27990269 doi: 10.12688/f1000research.10082.1
Bates, D., Mächler, M., Bolker, B. M. & Walker, S. C. Fitting linear mixed-effects models using lme4. J. Stat. Softw. 67, 1–48 (2015).
doi: 10.18637/jss.v067.i01
Pinheiro, J. & Bates, D. Linear and nonlinear mixed effects models (nlme). https://svn.r-project.org/R-packages/trunk/nlme/ (2011).
Fiumara, M., Ferrari, S., Beretta, S., Merelli, I. & Naldini, L. Genotoxic effects of base and prime editing in human hematopoietic stem cells. BAR-Seq, RNA-Seq. Gene Expression Omnibus https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE218464 (2023).
Fiumara, M., Ferrari, S., Beretta, S., Merelli, I. & Naldini, L. Genotoxic effects of base and prime editing in human hematopoietic stem cells. In vivo experiment with standard mRNA constructs. European Nucleotide Archive https://www.ebi.ac.uk/ena/browser/view/PRJEB58344 (2023).
Fiumara, M., Ferrari, S., Beretta, S., Merelli, I. & Naldini, L. Genotoxic effects of base and prime editing in human hematopoietic stem cells. HSPC derived colonies. European Nucleotide Archive https://www.ebi.ac.uk/ena/browser/view/PRJEB64207 (2023).
Fiumara, M., Ferrari, S., Beretta, S., Merelli, I. & Naldini, L. Genotoxic effects of base and prime editing in human hematopoietic stem cells. In vivo experiment with standard and optimized mRNA constructs. European Nucleotide Archive https://www.ebi.ac.uk/ena/browser/view/PRJEB64407 (2023).
Fiumara, M., Ferrari, S. & Naldini, L. Genotoxic effects of base and prime editing in human hematopoietic stem cells. Raw data. Mendeley https://doi.org/10.17632/mnpg6dp8fh.1 (2023).
Fiumara, M., Ferrari, S., Beretta, S., Merelli, I. & Naldini, L. Genotoxic effects of base and prime editing in human hematopoietic stem cells. Scripts for bioinformatic analysis. GitLab http://www.bioinfotiget.it/gitlab/custom/fiumara_baseprimeed2022 (2023).
Nestorowa, S. et al. A single-cell resolution map of mouse hematopoietic stem and progenitor cell differentiation. Blood 128, e20–e31 (2016).
pubmed: 27365425 pmcid: 5305050 doi: 10.1182/blood-2016-05-716480

Auteurs

Martina Fiumara (M)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.

Samuele Ferrari (S)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy. ferrari.samuele@hsr.it.
Vita-Salute San Raffaele University, Milan, Italy. ferrari.samuele@hsr.it.

Attya Omer-Javed (A)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Stefano Beretta (S)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Luisa Albano (L)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Daniele Canarutto (D)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.
Pediatric Immunohematology Unit and BMT Program, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Angelica Varesi (A)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Chiara Gaddoni (C)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Chiara Brombin (C)

University Center for Statistics in the Biomedical Sciences, Vita-Salute San Raffaele University, Milan, Italy.

Federica Cugnata (F)

University Center for Statistics in the Biomedical Sciences, Vita-Salute San Raffaele University, Milan, Italy.

Erika Zonari (E)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Matteo Maria Naldini (MM)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Matteo Barcella (M)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Bernhard Gentner (B)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Ivan Merelli (I)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
National Research Council, Institute for Biomedical Technologies, Segrate, Italy.

Luigi Naldini (L)

San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy. naldini.luigi@hsr.it.
Vita-Salute San Raffaele University, Milan, Italy. naldini.luigi@hsr.it.

Classifications MeSH