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Fecal microbiota transplant (FMT) is an investigational live biotherapeutic product being studied at Massachusetts General Hospital for the treatment of high-risk acute graft-versus-host disease (GVHD) in patients who have undergone allogeneic hematopoietic cell transplantation. The intervention involves the administration of live microorganisms from the stool of healthy donors to restore intestinal microbiome diversity. Disruption of the gut microbiome is associated with the development and severity of acute GVHD. By replenishing beneficial commensal bacteria, FMT aims to modulate the recipient's immune response and improve clinical outcomes. Researchers at Massachusetts General Hospital have conducted Phase 1 and Phase 2 clinical trials evaluating the feasibility and efficacy of third-party donor FMT, administered as oral capsules, for both treatment-naïve and steroid-refractory acute GVHD.
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