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Medicinal Products Based on Adeno-Associated Viral Vectors: A Regulatory Perspective on the Potential Risk of Insertion-Mediated Tumorigenesis

30 Sept 2025

Abstract excerpt

The first marketed gene therapy medicinal products based on adeno-associated virus (AAV-GTMP) show promise for the treatment of various diseases, including rare diseases with unmet medical needs. AAV is traditionally considered nonpathogenic to humans, is incapable of self-replication, and, after introduction into various cell types, remains primarily episomal. Several reports have examined the risks of AAV-GTMP,...

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Methodology Data sources Editorial policy Privacy About Contact Helena Bioinformatics

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PMID: 40789645
DOI: 10.1177/10430342251366314

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