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Production Assistance for Cellular Therapies (PACT): four-year experience from the United States National Heart, Lung, and Blood Institute (NHLBI) contract research program in cell and tissue therapies.

2009 Apr

Journal Article

Reed, W.; Noga, S.J.; Gee, A.P.; Rooney, C.M.; Wagner, J.E.; McCullough, J.; McKenna, D.H.; Whiteside, T.L.; Donnenberg, A.D.; Baker, A.K.; Lindblad, R.W.; Wagner, E.L.; Mondoro, T.Heath







Algorithms; Biological Specimen Banks; Cell- and Tissue-Based Therapy; Clinical Laboratory Techniques; Contracts; Education, Medical, Continuing; Humans; National Heart, Lung, and Blood Institute (U.S.); United States

BACKGROUND: In 2002, the US National Heart, Lung, and Blood Institute (NHLBI) conducted a workshop to determine needs of the cell therapy community. A consensus emerged that improved access to cGMP facilities, regulatory assistance, and training would foster the advancement of cellular therapy.STUDY DESIGN AND METHODS: A 2003 NHLBI request for proposals resulted in four contracts being awarded to three cell-manufacturing facilities (Baylor College of Medicine, University of Minnesota, and University of Pittsburgh) and one administrative center (The EMMES Corporation). As a result, Production Assistance for Cellular Therapies (PACT) was formed.RESULTS: As of October 1, 2008, PACT has received 65 preliminary applications of which 45 have been approved for product manufacture. A variety of cell therapies are represented including T-regulatory cells, natural killer cells, adipose-derived stem cells, cardiac progenitor cells for cardiac disease, hematopoietic progenitor cells (HPCs) for central nervous system applications, cytotoxic T lymphocytes, and dendritic cells. A total of 169 products have been administered under 12 applications and 2 reagents were manufactured and delivered. Fourteen peer-reviewed publications and 15 abstracts have resulted from the PACT project to date. A cell therapy textbook is nearly complete. PACT technical projects have addressed assay development, rapid endotoxin testing, shipping of cell products, and CD34+ HPC isolation from low-volume marrow. Educational Web seminars and on-site training through workshops have been conducted.CONCLUSIONS: PACT is an active and successful cell therapy manufacturing resource in the United States, addressing research and training while forging relationships among academia, industry, and participating institutions.

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