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Recently, the biopharmaceutical company Bluebird bio disclosed that the FDA has put its LentiGlobin gene therapy plan for sickle cell disease (SCD) on hold in the clinical stage.
FDA reported a case of acute myelogenous leukemia (AML) and may be associated with another embodiment of the treatment of myelodysplastic syndrome of the I HGB-206 / II study after the last week temporarily halted in clinical trials in After reporting a case of acute myeloid leukemia (AML) and another case of myelodysplastic syndrome that may be related to the treatment in the Phase I/II HGB-206 study, the company temporarily suspended the clinical trial last week
bluebird bio stated in its quarterly performance report: "We are investigating these incidents and plan to continue to work closely with the FDA during the review.
In the initial announcement, bluebird bio noted that the most recently diagnosed case of AML involved patients who underwent gene therapy more than five years ago in the HGB-206 study.
diagnosis
The red blood cells of patients with sickle cell disease contain abnormal hemoglobin (a protein that carries oxygen).
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