Moffitt Cancer Center has been selected as a Cell Therapies Processing Facility by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). Moffitt is one of five institutions that make up the NHLBI’s Production Assistance for Cellular Therapies (PACT) group. This exclusive group includes the only NHLBI-approved facilities to produce cell-based therapies for scientific research.
Cell-based therapies are treatment in which living cells are injected into a patient. Immunotherapy using T cells to fight cancer cells is an example of this. As part of the NHLBI PACT group, Moffitt will manufacture human cells that will be used to help develop early-stage clinical trials to evaluate the safety and effectiveness of new therapies.
“Being selected as one of the NHLBI’s PACT facilities recognizes Moffitt as a leader in cancer research and treatment. Cell therapy production is an extremely specialized area. There are strict requirements and regulations through the U.S. Food and Drug Administration that must be met,” said Linda L. Kelley, Ph.D., principal investigator and director of Moffitt’s Cell Therapy Facility. “Our scientists look forward to assisting the NHLBI and its partners with bridging the gap between basic and clinical research and generating possible new therapies for patients.”
The goal of the PACT program is to advance cellular therapy research in the areas of organs and biologic systems, damaged and diseased tissue regeneration, as well as create targeted treatments for serious diseases without effective therapies. The cell processing facilities are charged with implementing the rapid, safe and consistent transition of innovative treatment concepts to clinical practice, as well as supplying clinical-grade products produced in a manner that is compliant with applicable regulatory requirements.
The NHLBI provides each PACT group member with infrastructure funding. There is also the opportunity to receive additional funds as members receive and complete cell-based therapy requests from institutions across the country. The four other institutions that make up the PACT group include City of Hope, University of Miami, University of Minnesota and Baylor College of Medicine.