Delayed Safety Outcomes After Therapeutic Genome Editing: A Scoping Review of Clonal Dynamics, Genomic Alterations, Follow-Up Duration, and Adverse-Event Attribution in Clinical Translation

Therapeutic genome editing now spans ex vivo hematopoietic stem-cell products, engineered immune cells, and in vivo organ-directed treatment. Clinical outcomes can improve before rare or delayed genomic consequences become detectable. To distinguish observed delayed outcomes from mechanistic safety signals, and to examine how editing modality, clonal behavior, surveillance duration, sampling, and competing causes condition clinical interpretation. A PRISMA-ScR-aligned evidence-map design was specified around therapeutic genome editing and delayed genomic or clinical safety. Published clinical and translational reports were examined to establish the charting structure. A reproducible, enumerated database search and full-text selection ledger have not yet been completed; consequently, a final included-study denominator, evidence distribution, and PRISMA count are unavailable. Clinical studies document treatment activity and adverse events over defined follow-up periods; preclinical studies identify on-target structural lesions, editing-associated cellular responses, and modality-dependent changes in hematopoietic clonal persistence. These sources use non-equivalent assays and observational horizons. Long-term safety assessment requires longitudinal measurement of genomic lesions, clone identity, clinical outcomes, and competing exposures. The present manuscript remains a provisional evidence-mapping draft until the selection ledger and complete study-level extraction are verified.