Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects

Genome editing has recently evolved from a theoretical concept to a powerful and versatile set of tools. The discovery and implementation of CRISPR-Cas9 technology have propelled the field further into a new era. This RNA-guided system allows for specific modification of target genes, offering high...

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Main Authors: Busra Cetin, Fulya Erendor, Yunus Emre Eksi, Ahter D. Sanlioglu, Salih Sanlioglu
Format: Article
Language:English
Published: Cambridge University Press 2025-01-01
Series:Expert Reviews in Molecular Medicine
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Online Access:https://www.cambridge.org/core/product/identifier/S1462399425000109/type/journal_article
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author Busra Cetin
Fulya Erendor
Yunus Emre Eksi
Ahter D. Sanlioglu
Salih Sanlioglu
author_facet Busra Cetin
Fulya Erendor
Yunus Emre Eksi
Ahter D. Sanlioglu
Salih Sanlioglu
author_sort Busra Cetin
collection DOAJ
description Genome editing has recently evolved from a theoretical concept to a powerful and versatile set of tools. The discovery and implementation of CRISPR-Cas9 technology have propelled the field further into a new era. This RNA-guided system allows for specific modification of target genes, offering high accuracy and efficiency. Encouraging results are being announced in clinical trials employed in conditions like sickle cell disease (SCD) and transfusion-dependent beta-thalassaemia (TDT). The path finally led the way to the recent FDA approval of the first gene therapy drug utilising the CRISPR/Cas9 system to edit autologous CD34+ haematopoietic stem cells in SCD patients (Casgevy). Ongoing research explores the potential of CRISPR technology for cancer therapies, HIV treatment and other complex diseases. Despite its remarkable potential, CRISPR technology faces challenges such as off-target effects, suboptimal delivery systems, long-term safety concerns, scalability, ethical dilemmas and potential repercussions of genetic alterations, particularly in the case of germline editing. Here, we examine the transformative role of CRISPR technologies, including base editing and prime editing approaches, in modifying the genetic and epigenetic codes in the human genome and provide a comprehensive focus, particularly on relevant clinical applications, to unlock the full potential and challenges of gene editing.
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institution Kabale University
issn 1462-3994
language English
publishDate 2025-01-01
publisher Cambridge University Press
record_format Article
series Expert Reviews in Molecular Medicine
spelling doaj-art-2b049c8c98c64bafbcb7c9e36136d0642025-08-20T12:57:28ZengCambridge University PressExpert Reviews in Molecular Medicine1462-39942025-01-012710.1017/erm.2025.10Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospectsBusra Cetin0https://orcid.org/0000-0002-9644-7610Fulya Erendor1Yunus Emre Eksi2Ahter D. Sanlioglu3Salih Sanlioglu4https://orcid.org/0000-0001-8379-5678Department of Gene and Cell Therapy, Faculty of Medicine, Akdeniz University, Antalya, TurkeyDepartment of Gene and Cell Therapy, Faculty of Medicine, Akdeniz University, Antalya, TurkeyDepartment of Gene and Cell Therapy, Faculty of Medicine, Akdeniz University, Antalya, TurkeyDepartment of Gene and Cell Therapy, Faculty of Medicine, Akdeniz University, Antalya, TurkeyDepartment of Gene and Cell Therapy, Faculty of Medicine, Akdeniz University, Antalya, TurkeyGenome editing has recently evolved from a theoretical concept to a powerful and versatile set of tools. The discovery and implementation of CRISPR-Cas9 technology have propelled the field further into a new era. This RNA-guided system allows for specific modification of target genes, offering high accuracy and efficiency. Encouraging results are being announced in clinical trials employed in conditions like sickle cell disease (SCD) and transfusion-dependent beta-thalassaemia (TDT). The path finally led the way to the recent FDA approval of the first gene therapy drug utilising the CRISPR/Cas9 system to edit autologous CD34+ haematopoietic stem cells in SCD patients (Casgevy). Ongoing research explores the potential of CRISPR technology for cancer therapies, HIV treatment and other complex diseases. Despite its remarkable potential, CRISPR technology faces challenges such as off-target effects, suboptimal delivery systems, long-term safety concerns, scalability, ethical dilemmas and potential repercussions of genetic alterations, particularly in the case of germline editing. Here, we examine the transformative role of CRISPR technologies, including base editing and prime editing approaches, in modifying the genetic and epigenetic codes in the human genome and provide a comprehensive focus, particularly on relevant clinical applications, to unlock the full potential and challenges of gene editing.https://www.cambridge.org/core/product/identifier/S1462399425000109/type/journal_articleCRISPR/Casgenetic diseasesgene editinggene therapymedical genetics
spellingShingle Busra Cetin
Fulya Erendor
Yunus Emre Eksi
Ahter D. Sanlioglu
Salih Sanlioglu
Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects
Expert Reviews in Molecular Medicine
CRISPR/Cas
genetic diseases
gene editing
gene therapy
medical genetics
title Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects
title_full Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects
title_fullStr Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects
title_full_unstemmed Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects
title_short Advancing CRISPR genome editing into gene therapy clinical trials: progress and future prospects
title_sort advancing crispr genome editing into gene therapy clinical trials progress and future prospects
topic CRISPR/Cas
genetic diseases
gene editing
gene therapy
medical genetics
url https://www.cambridge.org/core/product/identifier/S1462399425000109/type/journal_article
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AT fulyaerendor advancingcrisprgenomeeditingintogenetherapyclinicaltrialsprogressandfutureprospects
AT yunusemreeksi advancingcrisprgenomeeditingintogenetherapyclinicaltrialsprogressandfutureprospects
AT ahterdsanlioglu advancingcrisprgenomeeditingintogenetherapyclinicaltrialsprogressandfutureprospects
AT salihsanlioglu advancingcrisprgenomeeditingintogenetherapyclinicaltrialsprogressandfutureprospects