Peroneal Tendon Injuries In Athletes: a Comprehensive Literature Review Of Diagnostic And Therapeutic Approaches

Cell and gene therapies are emerging as a potential game-changer treatment modality for some of the most challenging diseases that cannot be addressed with traditional drug treatments. These therapies involve the use of living cells, genetic material, viral or non-viral delivery systems and engineered biological platforms to repair, replace, modify or restore the cellular and molecular function. They are found to be beneficial in oncology, rare genetic diseases, retinal disorders, haemophilia, neurodegenerative disorders and regenerative medicine. Their biological complexity poses complex regulatory challenges however, along their product life cycle. Some of the key issues are product classification, manufacturing variability, potency testing, batch variability, donor or patient material quality, biodistribution, immunogenicity, off-target effects and long term safety. Clinical evaluation is also challenging as many products are being developed for small or rare disease populations, where traditional RCTs are not possible. Hence, it is important that post-market surveillance, patient traceability, real world evidence and long term follow-up are undertaken to monitor any delayed risks and therapeutic durability. Further complicating the process of regulatory decision-making are ethical and access issues, such as informed consent, affordability, market access and interventions that have not been proven or evaluated.

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