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The Stem Cell Research Newswire: Comprehensive Real-Time News Feed for Stem Cell Research

Tuesday, February 3, 2015

bluebird bio Release: FDA Grants Breakthrough Therapy Designation To...

"The FDA's Breakthrough designation of LentiGlobin highlights that new therapies are needed for the treatment of patients with beta-thalassemia major, especially treatments with the potential to meaningfully reduce or liberate patients from transfusion dependence" LentiGlobin BB305 Drug Product aims to treat beta-thalassemia major and severe sickle cell disease by inserting a functional human beta-globin gene into the patient's own hematopoietic stem cells ex vivo and then returning those modified cells to the patient through an autologous stem cell transplantation.

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