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Mesenchymal stromal cells (ex vivo cultured) is an autologous cell therapy developed by Fondazione IRCCS San Gerardo dei Tintori for the treatment of severe traumatic brain injury (TBI). The therapy utilizes mesenchymal stromal cells (MSCs) harvested from the patient's bone marrow, which are then expanded ex vivo under Good Manufacturing Practice (GMP) conditions. The therapeutic mechanism is primarily paracrine, involving the secretion of a wide range of bioactive molecules known as the secretome. These include anti-inflammatory cytokines and neurotrophic factors that help to modulate the immune response, reduce neuroinflammation, stabilize the blood-brain barrier, and promote neuroregeneration and angiogenesis. Clinical evaluation has focused on the safety and feasibility of intravenous administration in patients with severe TBI.
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