Box 1. Regulatory responses in Europe and the United States

From the following article:

The future of gene therapy

Marina Cavazzana-Calvo, Adrian Thrasher and Fulvio Mavilio

Nature 427, 779-781(26 February 2004)

doi:10.1038/427779a

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United States

The FDA allows gene-therapy trials for X-SCID if no other therapy is available. Clinical hold on other stem-cell gene-therapy trials may be lifted after case-by-case review.

right arrow http://www.fda.gov/ohrms/dockets/ac/03/minutes/3924M2.doc

United Kingdom

Approved clinical SCID trials are assessed on a case-by-case basis and are ongoing.

right arrow http://www.doh.gov.uk/genetics/gtac/recommendationsGTAC-CSM.PDF

France

After a temporary hold, the French reopened clinical studies for X-SCID in January 2004.

right arrow http://afssaps.sante.fr

Italy

Moratorium on any clinical trial involving the use of retroviruses until 31 December 2003. New ruling is currently awaited.

right arrow http://www.iss.it/sitp/scf1/comu/index.html

Germany

After a temporary hold on all trials involving retroviruses, gene-therapy trials for SCIDs and other diseases restarted in February 2003.

right arrow http://www.bundesaerztekammer.de/30/Ethik/ 80Themen/85KomSomGen

Europe

No Europe-wide regulations. Although experts argue that stem-cell gene-therapy trials should be allowed for life-threatening disorders after careful risk/benefit evaluation.

right arrow http://www.emea.eu.int/index/indexh1.htm

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