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May 8, 2026Annals of Medicine and SurgeryOpen Access

CRISPR-Cas9 off-target effects in urothelial gene therapy: the overlooked risk of P53 mutational signatures in bladder tissue

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Authors

SZSedaghat Dyl ZahraAAAzan AhmedVBVareesha Batool

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Overview

Randomized trial assesses off-target mutations in gene therapy for bladder pain syndrome, highlighting safety concerns.

Key Points

  • This research investigates the risks associated with CRISPR-Cas9 gene therapy in urothelial tissue, focusing on P53 mutation signatures.
  • Evaluated interstitial cystitis/BPS treatment using gene therapy via intravesical delivery.
  • Identified risks of off-target mutations affecting the TP53 gene during CRISPR-Cas9 interventions.
  • Recommended off-target mapping and genomic monitoring strategies for safety assessment.
  • Confirmed the presence of low-frequency TP53 mutations from off-target effects, with clinically relevant implications.
  • Demonstrated a need for long-term genomic surveillance post-gene therapy to detect potential malignancies.
  • Highlighted the inadequacy of current safety studies to account for off-target genomic interactions.

Cite This Study

Zahra et al. (2026) studied this question.

synapsesocial.com/papers/69fd7d94bfa21ec5bbf05eeahttps://doi.org/10.1097/ms9.0000000000005079
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1CRISPR/Cas9-mediated miR-21 editing in high-grade urothelial carcinoma cells and its biological effects2026
  2. 2CRISPR-based gene expression platform for precise regulation of bladder cancer2024 · 2 citations
  3. 3Gene-mediated therapy for BCG-unresponsive nonmuscle-invasive bladder cancer: mechanisms, clinical evidence, and practical implementation2025
  4. 4Abstract PR009: Exploring the functional consequences of APOBEC3-induced non-coding hotspot mutations in bladder cancer using massively parallel reporter assays and CRISPR-mediated base editing2024
  5. 5Epigenetic evolution of bladder cancer from cellular origin to clinical translation2026