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The application of somatic cell gene therapy to large patient populati
ons will require the development of safe and practical approaches to t
he generation and characterization of genetically manipulated cells. T
ranskaryotic implantation is a gene therapy system based on the produc
tion of clonal strains of engineered primary and secondary cells, usin
g nonviral methods. We demonstrate here that, on implantation, these c
lonal cell strains stably and reproducibly deliver pharmacologic quant
ities of protein for the lifetime of the experimental animals.