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In gene therapy, vector–chromatin interaction and its consequences have become more unpredictable, but vector-induced leukemogenesis remains an predictable factor in gene therapy due to its multifactorial nature.
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Indeed, the success and feasibility of gene therapy is undeniable considering that the majority of the more than 60 patients treated for ADA-SCID and SCID-X1 within the last two decades experienced a clear clinical benefit.
Despite the occurrence of leukemia in some of these patients the overall success rate of gene therapy outperforms the results obtained after allogeneic HSCT with HLA-mismatched donors.
Potential adverse effects of gene therapy have to be balanced against the clinical benefit expected for the individual patient, taking into consideration the clinical complications associated with alternative treatment options.
Gene therapy may cause off-target effects and there is a risk that the new gene will insert itself into the path of another gene, disrupting its activity or causing insertional mutagenesis.
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