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Allogeneic bone marrow-derived mesenchymal stromal cells (BMMSCs) is an investigational cell-based biologic and advanced therapy medicinal product (ATMP) developed by Leiden University Medical Center (LUMC). The therapy consists of living mesenchymal stromal cells harvested from the bone marrow of healthy allogeneic donors. BMMSCs exert immunomodulatory and tissue-regenerative effects by suppressing local inflammatory immune responses and promoting mucosal healing. In clinical studies, these cells are administered via endoscopic local injection into the rectal wall for the treatment of refractory moderate-to-severe ulcerative colitis (specifically ulcerative proctitis) and have also been investigated for refractory perianal fistulizing Crohn's disease. A Phase IIa study published in JCI Insight (2023) demonstrated that the local administration was safe, feasible, and well-tolerated, showing encouraging signs of clinical efficacy in patients who had failed conventional therapies.
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