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This investigational cell therapy consists of a single intravenous infusion of non-human leukocyte antigen (HLA) matched, ABO matched, unrelated allogeneic umbilical cord blood (UCB) for the treatment of acute ischemic stroke. Developed by Dr. Joanne Kurtzberg and researchers at Duke University, the therapy utilizes the diverse cellular components of cord blood, including hematopoietic stem cells and mesenchymal stromal cells, to exert therapeutic effects. The mechanism of action is primarily mediated through paracrine signaling, where the infused cells release cytokines and growth factors that modulate the immune response, reduce neuroinflammation, and promote endogenous neurogenesis and angiogenesis in the damaged brain tissue. Clinical evaluation in the Phase 1 CoBIS study (NCT02397018) demonstrated that the treatment is well-tolerated when administered 3-10 days post-stroke, supporting further investigation in randomized controlled trials.
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