THE IMMUNOLOGIC MONITORING AND CELLULAR PRODUCTS LABORATORY (IMCPL) will assume responsibility for providing immunologic laboratory support for the Programs in this Program Project. The specific objectives of this core will be to: 1) procure, process and bank human brain tumor or tissue specimens as well as body fluids for all projects; 2) establish human glioblastoma cell lines from tumor biopsies and maintain as well as expand these lines for pre-clinical studies; 3) measure or serially monitor cytokines and selected growth factors in the tumor microenvironment, body fluids or in cell supernatants; 4) develop, evaluate and perform monitoring assays to assess effects of immunotherapy or drug therapy on functions of immune cells, including apoptosis; 5) using ELISPOT assays for IFN-gamma production, to monitor changes in the frequency of anti-tumor CTL as a result of cytokine or cytokine+ vaccine administration to patients with brain tumors; 6) culture and evaluate characteristics of human dendritic cells (DC) for use in pre-clinical and clinical studies; 7) generate and provide quality cellular products, including fibroblasts, tumor cells or DC, transduced with the cytokine genes and secreting cytokines, specifically IL-4 for therapy of patients participating in clinical trials performed as a part of the Program; 8) perform safety testing on genetically-modified therapeutic products; 9) interact with investigators in projects 1 to 3 in the development of genetically-modified human cellular products for in vivo and in vitro pre-clinical studies; 10) Perform evaluations of quality and sterility for all cultures and products designed for clinical use. To meet these diverse requirements, the Core will be organized into discrete units as follows: a) a cell product generation laboratory dedicated to culture, maintenance, genetic modification and selection of human cells for therapy; b) a tissue procurement and processing laboratory; c) a immunologic monitoring and cytokine unit; and d) a research laboratory for developmental preclinical studies. The IMCPL will operate according to the FDA guidelines for preparation of biologic products for therapy and will maintain good laboratory practice (GLP) standards.
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