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Despite advances in insulin delivery and glucose monitoring technologies, patients remain at risk for acute and long\u2010term complications, underscoring the need for curative strategies. Gene therapy and gene\u2010editing technologies are emerging as transformative approaches capable of restoring \u03b2\u2010cell function, modulating immune responses and potentially achieving durable remission.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method<\/jats:title>\n                    <jats:p>This review synthesizes basic science foundations and clinical trial evidence, focusing on five key protocols (NCT03162237, NCT05210530, NCT05241444, NCT05565248 and NCT06938334).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Strategies include immune modulation (PD\u2010L1, FOXP3), \u03b2\u2010cell replacement (CRISPR\u2010edited progenitors, xenotransplantation) and combination approaches. Early\u2010phase clinical trials have demonstrated feasibility and safety; however, long\u2010term efficacy, durability and scalability remain uncertain. Critical challenges include potential off\u2010target effects in CRISPR editing, risks of insertional mutagenesis, safety concerns in xenotransplantation and achieving a balance between immune tolerance and protective immunity. Future directions emphasize combination therapies, personalized medicine and next\u2010generation editing tools such as base and prime editing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Together, these efforts represent a paradigm shift from symptomatic insulin replacement toward curative interventions, while highlighting the considerable translational hurdles that must be overcome before routine clinical application.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.70800","type":"journal-article","created":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T09:14:14Z","timestamp":1776935654000},"page":"5476-5491","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Gene Therapy and Gene Editing in Type 1 Diabetes:\n                    <scp>CRISPR<\/scp>\n                    \u2010Based \u03b2\u2010Cell Replacement and Treg Immune Modulation Approaches"],"prefix":"10.1111","volume":"28","author":[{"given":"Tzu\u2010Min","family":"Lin","sequence":"first","affiliation":[{"name":"Digital Transformation Research Institute Institute for Information Industry  Taipei Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui\u2010Fang","family":"Chang","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Department of Internal Medicine Hsinchu Mackay Memorial Hospital  Hsinchu Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tzu\u2010Ching","family":"Lin","sequence":"additional","affiliation":[{"name":"Division of Pharmacy Koo Foundation Sun Yat\u2010Sen Cancer Center  Taipei Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng\u2010Han","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Biological Science and Technology National Yang Ming Chiao Tung University  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