• FDA clears IND application for stem cell therapy to treat AML

    9 days ago - By Healio

    The FDA cleared an investigational new drug application for VOR33, an engineered stem cell therapy for the treatment of patients with acute myeloid leukemia who are at high risk for relapse, according to the agent's manufacturer.
    VOR33 is a hematopoietic stem cell therapy that is genetically engineered to lack the CD33 protein. Removal of this protein allows for subsequent treatment with gemtuzumab ozogamicin - a CD33-directed antibody drug conjugate - while avoiding the known toxicities of CD33-directed therapies.
    The IND clearance will
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  • Stromal/stem cell implant improves motor function in patients with history of TBI

    9 days ago - By Healio

    Patients with previous traumatic brain injury experienced significant improvement in motor functioning after implantation of mesenchymal stromal/stem cells, according to interim data from the STEMTRA phase 2 trial published in Neurology.
    “Mesenchymal stromal/stem cell implantation is a promising strategy for the treatment of TBI,” Masahito Kawabori, MD, PhD, of the department of neurosurgery at Hokkaido University Hospital in Sapporo, Japan, and colleagues wrote. “Allogeneic modified bone marrow-derived MSCs are in clinical development for
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