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This investigational cell therapy, developed by The Cleveland Clinic, consists of allogeneic bone marrow-derived mesenchymal stem cells (MSCs) for the treatment of medically refractory pouchitis. The treatment involves a submucosal endoscopic injection of 60 million cells into the ileal pouch of patients who have undergone proctocolectomy with ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis. The therapy is designed to leverage the anti-inflammatory and regenerative properties of MSCs to alter the local inflammatory milieu and the ileal pouch microbiome. It is currently being evaluated in a Phase I clinical trial (NCT05578508) to assess safety and feasibility.
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