Clinical trial on patients with alpha 1 antitrypsin deficiency

GMO Register No: G0362-01

Reference No: B/IE/10/362

Decision

On 11 August 2010, the Environmental Protection Agency (EPA) granted consent, subject to specified conditions, to Applied Genetics Technologies Corporation, USA to carry out a clinical trial on patients suffering from alpha-1 antitrypsin deficiency, using a genetically modified micro-organism, at Beaumont Hospital in Dublin, from August 2010 to July 2011.  This trial did not proceed.

Relevant Documentation

Inspector’s Report
Consent Conditions
GMO Register G0362-01

GMO Register

The trial was assigned GMO Register No G0362-01. The Register provides significant details about the trial.

Legislation

Any person or organisation proposing to carry out a deliberate release of a genetically modified organism (GMO) for purposes other than placing on the market (performance of field trials) must comply with the legislative requirements set out under Part II of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003.