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Successful Preclinical Development of Gene Therapy for Recombinase-Activating Gene-1-Deficient SCID. | LitMetric

AI Article Synopsis

Article Abstract

Recombinase-activating gene-1 (RAG1)-deficient severe combined immunodeficiency (SCID) patients lack B and T lymphocytes due to the inability to rearrange immunoglobulin and T cell receptor genes. Gene therapy is an alternative for those RAG1-SCID patients who lack a suitable bone marrow donor. We designed lentiviral vectors with different internal promoters driving codon-optimized to ensure optimal expression. We used mice as a preclinical model for RAG1-SCID to assess the efficacy of the various vectors. We observed that B and T cell reconstitution directly correlated with expression. Mice with low expression showed poor immune reconstitution; however, higher expression resulted in phenotypic and functional lymphocyte reconstitution comparable to mice receiving wild-type stem cells. No signs of genotoxicity were found. Additionally, RAG1-SCID patient CD34 cells transduced with our clinical RAG1 vector and transplanted into NSG mice led to improved human B and T cell development. Considering this efficacy outcome, together with favorable safety data, these results substantiate the need for a clinical trial for RAG1-SCID.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7163047PMC
http://dx.doi.org/10.1016/j.omtm.2020.03.016DOI Listing

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