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While Old World monkeys, for example, baboons, have antibodies against triple‐knockout (TKO) pig cells, thus complicating pig organ transplantation studies, capuchin monkeys (a New World monkey) do not, thus more closely mimicking humans in respect to the response to TKO pig cells. Whether drugs...
Progress has been made in overcoming antibody‐mediated rejection of porcine xenografts by deleting pig genes that produce unique carbohydrate epitopes. Pigs deficient in galactose α‐1,3 galactose (gene modified: GGTA1) and neu5Gc (gene modified: CMAH) have reduced levels of human antibody...
The United States Food and Drug Administration's (FDA) regulatory approach for xenotransplantation products and xenografts encompasses regulatory considerations for biological products, medical devices, drugs, combination products, and genetically altered animals, depending on the product. This...
The transplanted organs or cells survive if the recipient receives adequate long‐term immunosuppressive therapy. Immunosuppressive therapy combined with cell‐based strategies (eg, regulatory T cell [Treg]‐based therapy) promotes graft survival. A combination of Treg‐based therapy and minimal or...
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