Nucleic acid therapies, which involve the transfer of exogenous genes into target cells, are promising clinical treatments that can regulate gene expression at the transcriptional or posttranscriptional level.
Ideally, this treatment will not lead to an unwanted immune response. Compared to traditional treatments, nucleic acid therapeutic agents can achieve a long-lasting and stable therapeutic effect. As a new treatment, therapeutic nucleic acids are playing an increasingly important role in clinical conditions for the treatment of various conditions, including infectious diseases, cancer, immune diseases and monogenetic diseases.
To date, a large number of clinical trials have been conducted, more than 30 nucleic acid preparations have been approved, highlighting the strong potential of this approach in clinical practice. A variety of media are used for protection nucleic acids from degradation and help them accurately achieve their goals. However, it is known that some carriers cause adverse effects on the release and expression of nucleic acid preparations, as well as side effects such as allergic reactions and accumulation in the liver. Therefore, the assessment of the biosafety of delivery systems before their application in a clinical setting is crucial.
In this review appears in Biosafety and healthThe authors describe different delivery systems for nucleic acid drugs and discuss their biosecurity in both preclinical and clinical trialswith special attention to the carriers themselves, the method of drug administration and general treatment of the disease.
Zhimin Li et al, Biosafety Assessment of Delivery Systems for Clinical Therapeutic Nucleic Acids, Biosafety and health (2022). DOI: 10.1016 / j.bsheal.2022.03.003
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