In what the authors call the first study of its kind, a team of researchers at the non-profit Caring Cross have successfully used point-of-care manufacturing technology to create T-cells to treat patients with B-cell malignancies – specifically, children with acute lymphocytic leukemia and adults with non-Hodgkin lymphoma.
Point-Of-Care Manufacturing Successfully Treats B-Cell Cancers; How Will FDA Regulate It?
In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.
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