Retroviral Vectors

FDA temporarily halts some gene therapy trials

Published in Gene Therapy Weekly, February 6th, 2003

In a precautionary measure, the U.S. Food and Drug Administration (FDA) has placed on "clinical hold" all active gene therapy trials using retroviral vectors to insert genes into blood stem cells.

FDA took this action after it learned that a second child treated in a French gene therapy trial has developed a leukemia-like condition. Both this child, and another who had developed a similar condition in August 2002, had been successfully treated by gene therapy for X-linked severe combined immunodeficiency disease (X-SCID), also known as "bubble baby syndrome."

Infants with X-SCID have a gene defect that leads to a complete lack of white blood cells...

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Source: Gene Therapy Weekly (2003-02-06)

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