This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.
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The number of subjects with malignancies
Timeframe: Up to 15 years post-drug product infusion
The number of subjects with immune-related AEs
Timeframe: Up to 15 years post-drug product infusion
The number of subjects with new or worsening hematologic disorders
Timeframe: Up to 15 years post-drug product infusion
The number of subjects with new or worsening neurologic disorders
Timeframe: Up to 15 years post-drug product infusion