The overall goal of the Cell Therapies Core (CTC) is to provide service to members to facilitate translation of promising therapies for patients with cancer. The CTC manufactures cellular products in support of novel, investigator-initiated clinical studies, while maintaining compliance with standards set by the U.S. Food and Drug Administration (FDA) and other accrediting bodies. To accomplish this goal, the CTC's Specific Aims are to: 1) Develop new technologies for translation of cellular therapies 2) Provide regulatory assistance in support of cellular therapies 3) Educate and train scientists and clinicians committed to careers in cellular therapies 4) Produce the highest quality cellular products for immunotherapy clinical trials The CTC works with members through all stages of a clinical trial, including collaboration during pre-clinical planning. The CTC technical director, manager, and quality staff assist with preparation of protocols, funding/grant applications, INDs, and other regulatory submissions. Once the cellular therapy agent under study is administered to the patient, the CTC analytic laboratory may continue to assist in post-treatment immune monitoring or, when desired by investigators, may directly conduct the immune monitoring studies. The CTC has four key areas of activity: 1. New product development, wherein new cell therapy products undergo pre-clinical scale-up, testing, and validation 2. Cell collection and cryostorage to obtain mononuclear cells, lymphocytes, and antigen presenting cells for production of cell therapy products and immune monitoring studies 3. Cell therapy product manufacturing, including dendritic and tumor cell-based gene-modified and un- modified vaccines and purification and/or expansion of T lymphocytes (T regulatory cells, tumor infiltrating lymphocytes, tumor antigen-associated T cells, chimeric antigen receptor T cells) 4. An analytic laboratory that performs the dual functions of product quality testing and post-treatment immune monitoring During the project period, the CTC supported 19 cancer center investigators involved in 27 projects and 39 publications. In FY2015, the CTC supported 15 projects, of which 87% represented member projects and 55% of total usage supported peer-review-funded members.
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