Moyo Buhle, Brown Lucas B C, Khondaker Ishika I, Bao Gang
Department of Bioengineering, Rice University, Houston, TX, 77030, USA.
Department of Bioengineering, Rice University, Houston, TX, 77030, USA; Graduate Program in Systems, Synthetic, and Physical Biology, Rice University, Houston, TX, 77030, USA.
Biomaterials. 2025 Oct;321:123314. doi: 10.1016/j.biomaterials.2025.123314. Epub 2025 Apr 2.
The recent approval of the first gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia by the U.S. Food and Drug Administration (FDA) demonstrates the immense potential of CRISPR (clustered regularly interspaced short palindromic repeats) technologies to treat patients with genetic disorders that were previously considered incurable. While significant advancements have been made with ex vivo gene editing approaches, the development of in vivo CRISPR/Cas gene editing therapies has not progressed as rapidly due to significant challenges in achieving highly efficient and specific in vivo delivery. Adeno-associated viral (AAV) vectors have shown great promise in clinical trials as vehicles for delivering therapeutic transgenes and other cargos but currently face multiple limitations for effective delivery of gene editing machineries. This review elucidates these challenges and highlights the latest engineering strategies aimed at improving the efficiency, specificity, and safety profiles of AAV-packaged CRISPR/Cas systems (AAV-CRISPR) to enhance their clinical utility.
美国食品药品监督管理局(FDA)最近批准了首款用于治疗镰状细胞病和输血依赖型β地中海贫血的基因编辑疗法,这证明了CRISPR(成簇规律间隔短回文重复序列)技术在治疗以前被认为无法治愈的遗传疾病患者方面具有巨大潜力。虽然体外基因编辑方法已经取得了重大进展,但由于在实现高效、特异性的体内递送方面存在重大挑战,体内CRISPR/Cas基因编辑疗法的发展并未如此迅速。腺相关病毒(AAV)载体作为递送治疗性转基因和其他货物的载体,在临床试验中已显示出巨大前景,但目前在有效递送基因编辑工具方面面临多重限制。本综述阐述了这些挑战,并重点介绍了旨在提高AAV包装的CRISPR/Cas系统(AAV-CRISPR)的效率、特异性和安全性,以增强其临床实用性的最新工程策略。