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This investigational cell therapy consists of allogeneic mesenchymal stromal cells (MSCs) developed by the Ottawa Hospital Research Institute for the treatment of septic shock. The therapy functions as an immunomodulatory biologic that works by dampening systemic inflammation, enhancing the clearance of pathogens, and facilitating tissue repair. The program's initial Phase I trial (CISS) utilized freshly cultured bone marrow-derived MSCs and established the safety and tolerability of the approach at doses up to 3.0 million cells/kg. Following the completion of the Phase I study, the development program progressed to a Phase II trial (UC-CISS II) evaluating cryopreserved umbilical cord-derived MSCs. The cells are produced to clinical-grade standards at The Ottawa Hospital Cell Manufacturing Facility.
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