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  • From Bench to Bedside: The Clinical Translation Gap in Cancer Nanomedicine

  • Masouma Nazari,1 Mahsa Asadi,2 Ahmad Reza Bahrami,3 Tara Akhtarkhavari,4 Maryam M Matin,5,*
    1. Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran.
    2. Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran.
    3. Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran.
    4. Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran.
    5. Department of Biology, Faculty of Science, Ferdowsi University of Mashhad, Mashhad, Iran.


  • Introduction: Nanoparticles hold great promise for tumor targeted drug delivery due to their ability to improve therapeutic index and reduce systemic toxicity in preclinical studies. However, despite extensive research, clinical translation of nanoparticle-based therapies remains limited, with inconsistent efficacy. This review aims to categorize and elucidate the underlying reasons for the clinical translation gap in cancer nanomedicine.
  • Methods: A comprehensive literature review was conducted, analyzing publications indexed in PubMed, Scopus, and Web of Science from 2020 to 2024. The data were synthesized to identify and classify the predominant challenges impeding clinical translation.
  • Results: The identified challenges were categorized into three groups: A) Nanoparticle Factors: These include physicochemical complexities such as variations in size, shape, and surface charge; protein corona formation altering biodistribution; manufacturing scalability and reproducibility issues; stability concerns leading to premature drug release; and batch to batch variations. B) Host Factors: Patient-specific variables like tumor heterogeneity affecting nanoparticle accumulation; immune system clearance reducing circulation time; off-target accumulation causing toxicity; and genetic variability leading to inconsistent therapeutic responses. C) Viability and Reliability of Tests: Challenges encompass inadequate preclinical models that fail to mimic human tumor biology accurately; regulatory uncertainties due to lack of standardized guidelines; high costs; and limited long-term safety data.
  • Conclusion: Thus, the clinical translation of nanoparticle-based cancer therapies is impeded by a complex interplay of nanoparticle design issues, patient-specific factors, and limitations in current testing methodologies. Addressing these multifaceted challenges requires interdisciplinary collaborations, standardized regulatory frameworks, and innovative research approaches to bridge the gap between laboratory findings and clinical applications in the future.
  • Keywords: Nanoparticle, Cancer, Clinical translation, Drug delivery

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