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FDA halts gene therapy trials after leukaemia case in France

BMJ 2003; 326 doi: (Published 25 January 2003) Cite this as: BMJ 2003;326:181
  1. Charles Marwick
  1. Washington, DC

    After the second occurrence of a leukaemia type illness in a patient in a gene therapy trial in France for X linked severe combined immune deficiency disorder (SCID), the US Food and Drug Administration has halted all trials that use retroviral vectors for inserting genes into bone marrow stem cells.

    The move is described as a “precautionary measure” pending investigation. No evidence has been shown of leukaemia in any of the patients in the United States who have had this type of gene transfer, says the FDA.

    Last September …

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