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PCR and other test systems in human gene therapy.

Three protocols using retroviral-mediated gene transfer are currently undergoing clinical trials. The uniqueness of these protocols, which were the first approved experiments in which genetically engineered cells were administered to human beings, necessitated the development of novel biological and physical safety testing procedures. In addition to standard testing for contamination with exogenous pathogens and toxins, specific tests were developed to assay for the presence of recombinant helper virus in both retroviral vector preparations and in the engineered human cells. Two new assays were developed, an enhanced S+/L-virus assay called 3T3 amplification, and a specific polymerase chain reaction protocol of great sensitivity. The results of these safety tests, along with pre-clinical primate safety studies, and the accumulating clinical data, suggest that retroviral-mediated gene transfer does not pose any serious short-term safety problems for patients enrolled in gene therapy protocols.