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Darvadstrocel is a suspension of expanded human allogeneic adipose-derived mesenchymal stem cells (eASC) used as an advanced cell therapy for the treatment of complex perianal fistulas in adults with non-active or mildly active luminal Crohn's disease, particularly after inadequate response to at least one conventional or biologic therapy. The product is administered via injection directly into the site of tissue injury. Its mechanism of action involves immunomodulatory and anti-inflammatory effects: upon activation by inflammatory cytokines such as IFN-γ, darvadstrocel suppresses T cell activation and proliferation, impairs dendritic cell differentiation and function, reduces B-cell differentiation, and inhibits natural killer cell proliferation. This leads to a reduction in pro-inflammatory cytokine secretion and promotes an anti-inflammatory microenvironment that supports tissue healing around the fistula tract. Darvadstrocel was first approved in Europe in 2018 under the brand name Alofisel; it was developed by TiGenix (later acquired by Takeda), with subsequent approvals including Japan[1][2][3][5][7].
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