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Sadly, a Seattle patient, who was part of a gene therapy clinical trial for inflammatory arthritis, died unexpectedly. As a result the FDA called a halt to the clinical trial.

The company conducting the clinical trial, Targeted Genetics, notified the FDA when the patient died. The clinical trial will remain on hold until the cause for her death can be determined.

The study involved a process called a vector, which delivers treatment genes to particular target cells. The gene therapy was injected directly into the diseased joints with the intent to reduce the inflammation. Over 100 subjects participated in the study without serious consequences.

Because the woman’s illness (and subsequent death) was related to her 2nd injection of the treatment the FDA felt it was important to determine if the illness was directly related to the gene therapy study.

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