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Mreg_UKR is a cell-based medicinal product containing human regulatory macrophages (Mregs). These cells are derived from CD14+ peripheral blood monocytes cultured with macrophage colony-stimulating factor and high concentrations of heat-inactivated human serum, followed by stimulation with interferon-gamma. Mregs are characterized by their unique immunoregulatory phenotype, including potent T cell suppressor function mediated through interferon-gamma–induced indoleamine 2,3-dioxygenase activity and contact-dependent deletion of activated T cells. They also promote the development of induced regulatory T cells that further suppress effector T cell proliferation and activity. Mreg_UKR has been developed as an adjunct immunosuppressive agent for use in solid organ transplantation, particularly kidney transplantation, with the aim of minimizing maintenance immunosuppression. Preclinical pharmacokinetic, safety pharmacology, and toxicological studies identified no acute or chronic adverse reactions to the product in animal models. Clinical trials have begun to assess its safety and efficacy in transplant recipients[1][2][3][5].
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