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Gene therapy fault puts medtech under spotlight:

This article was originally published in Clinica

Executive Summary

Italy, France, Germany and the US have temporarily halted gene therapy trials, after a French patient being treated for x-linked severe combined immunodeficiency (X-SCID) developed leukaemia. The UK, however, has stopped short of halting such research, in the belief that the benefits far outweigh the risks. In early 2000, the US FDA halted an angiogenesis trial using vascular endothelial growth-factor 2 (VEGF-2), after Vascular Genetics delayed reporting the death of two patients (see Clinica No 899, p 22). The scientific community, however, gave unqualified support for the safety and potential efficacy of gene therapy (see Clinica No 900, p 15). Worldwide there are 636 completed, ongoing or pending gene therapy trials, used to treat a range of conditions, from advanced breast cancer to coronary heart disease.

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