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This investigational cell therapy consists of allogeneic human mesenchymal stem cells (hMSCs) derived from bone marrow aspirates of a single, pre-clinically validated healthy donor. Developed by University Hospitals Cleveland Medical Center in collaboration with Case Western Reserve University and the National Center for Regenerative Medicine, the therapy is specifically designed to address the pathophysiology of cystic fibrosis (CF) lung disease. The hMSCs function by attenuating pulmonary inflammation and enhancing the body's ability to clear bacterial infections, potentially increasing the efficacy of co-administered antibiotics. As a mutation-agnostic treatment, it is intended for CF patients regardless of their specific CFTR mutation status, including those who do not respond to or tolerate standard CFTR modulator therapies. The therapy is administered as a single intravenous infusion and has been evaluated for safety and tolerability in the Phase I CEASE-CF clinical trial.
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