An initiative began in 1992 to develop a laboratory where gene therapy vectors could be produced and used in clinical trials according to FDA requirements. This Core Laboratory, known as the Human Gene Therapy Applications Laboratory (HGTAL) was the result of this initiative. We propose to expand the HGTAL to accommodate the interests being developed in the Cytokine Gene Therapy of Cancer Program Project. With the development of new programs on gene therapy and with the emergence of a clinically targeted gene therapy Program Project at the University of Pittsburgh, a centralized facility for the production and application of gene transfer vectors is critical. The objective of the HGTAL is to use previously tested systems of gene transfer including, but not limited to, replication defective retroviruses, adenoviruses, adeno-associated viruses, expression plasmids for use in bioballistic delivery of genes and liposomes for the delivery of genes to human cells in approved clinical trials of gene therapy. The HGTAL is a clinical applications support facility to be used in clinical trials of gene therapy in approved protocols. The first protocol which requires the services of this unit will be one for development of IL-12 retroviral vectors. We also will early develop a need for screening and testing other cytokine vectors noted above (IL-4, IL-1, IL-10, GM-CSF, etc.). Vectors to be used in this facility will have been thoroughly tested in pre-clinical studies and will have received RAC and FDA approval for clinical trials. Generally, this means that evidence will exist for potential efficacy, feasibility, and safety of the vector in human subjects. Having received appropriate approvals and after having characterized the vector and any necessary cell lines, the materials will be admitted to the facility storage areas. An appropriate second location backup storage at a certified site will be required.
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