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- W1833159727 abstract "Cell-based therapies are being developed for the treatment of degenerative diseases, inflammatory conditions, cancer, and repair of damaged tissue. Safety depends on many factors including the cell type, the differentiation status and proliferation capacity of the cells, the intended clinical condition, and the long-term survival of the product. Understanding the characteristics and function of the cellular therapy is crucial to the development of the nonclinical safety program that will support translation to the clinic. In addition to traditional local and systemic safety assessments, the potential for tumorigenicity, biodistribution, and immunogenicity of the cell therapy need to be addressed. The nonclinical strategy is product specific and designed on a case-by-case basis. Regular interaction with the regulatory agencies is advised to ensure acceptability of the proposed nonclinical plans. This chapter aims to provide advice on the aspects to consider when designing the nonclinical programs, potential limitations and how to address these, and to introduce the concept of the risk-based approach." @default.
- W1833159727 created "2016-06-24" @default.
- W1833159727 creator A5002882276 @default.
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- W1833159727 creator A5040145591 @default.
- W1833159727 creator A5059562010 @default.
- W1833159727 creator A5079896818 @default.
- W1833159727 date "2016-01-01" @default.
- W1833159727 modified "2023-09-24" @default.
- W1833159727 title "Nonclinical Studies for Cell-Based Medicines" @default.
- W1833159727 cites W1481698462 @default.
- W1833159727 cites W1567235082 @default.
- W1833159727 cites W1601405552 @default.
- W1833159727 cites W1719320996 @default.
- W1833159727 cites W1762167066 @default.
- W1833159727 cites W1963756017 @default.
- W1833159727 cites W1964001112 @default.
- W1833159727 cites W1972187551 @default.
- W1833159727 cites W1972902564 @default.
- W1833159727 cites W1977910761 @default.
- W1833159727 cites W1980933256 @default.
- W1833159727 cites W1983967814 @default.
- W1833159727 cites W1984567171 @default.
- W1833159727 cites W1988830115 @default.
- W1833159727 cites W1992624523 @default.
- W1833159727 cites W1993082468 @default.
- W1833159727 cites W1993120458 @default.
- W1833159727 cites W1994411144 @default.
- W1833159727 cites W1995286643 @default.
- W1833159727 cites W1998883576 @default.
- W1833159727 cites W1999202962 @default.
- W1833159727 cites W2002358384 @default.
- W1833159727 cites W2008729480 @default.
- W1833159727 cites W2009230048 @default.
- W1833159727 cites W2020312840 @default.
- W1833159727 cites W2023068069 @default.
- W1833159727 cites W2025371271 @default.
- W1833159727 cites W2028593954 @default.
- W1833159727 cites W2037338370 @default.
- W1833159727 cites W2040646120 @default.
- W1833159727 cites W2041165273 @default.
- W1833159727 cites W2041490487 @default.
- W1833159727 cites W2043840220 @default.
- W1833159727 cites W2045899482 @default.
- W1833159727 cites W2047942455 @default.
- W1833159727 cites W2050368977 @default.
- W1833159727 cites W2050600834 @default.
- W1833159727 cites W2054963453 @default.
- W1833159727 cites W2055648257 @default.
- W1833159727 cites W2056431833 @default.
- W1833159727 cites W2057159461 @default.
- W1833159727 cites W2059378220 @default.
- W1833159727 cites W2061225353 @default.
- W1833159727 cites W2061981400 @default.
- W1833159727 cites W2065594892 @default.
- W1833159727 cites W2067799053 @default.
- W1833159727 cites W2070780294 @default.
- W1833159727 cites W2071866729 @default.
- W1833159727 cites W2077806591 @default.
- W1833159727 cites W2078858529 @default.
- W1833159727 cites W2079240923 @default.
- W1833159727 cites W2080530966 @default.
- W1833159727 cites W2084211340 @default.
- W1833159727 cites W2084996241 @default.
- W1833159727 cites W2085326091 @default.
- W1833159727 cites W2086943348 @default.
- W1833159727 cites W2088232434 @default.
- W1833159727 cites W2091302289 @default.
- W1833159727 cites W2091696067 @default.
- W1833159727 cites W2092633851 @default.
- W1833159727 cites W2098459519 @default.
- W1833159727 cites W2102020781 @default.
- W1833159727 cites W2110463517 @default.
- W1833159727 cites W2113528471 @default.
- W1833159727 cites W2114190644 @default.
- W1833159727 cites W2115740727 @default.
- W1833159727 cites W2116503335 @default.
- W1833159727 cites W2118796952 @default.
- W1833159727 cites W2120121992 @default.
- W1833159727 cites W2122403086 @default.
- W1833159727 cites W2125987139 @default.
- W1833159727 cites W2126238164 @default.
- W1833159727 cites W2127405798 @default.
- W1833159727 cites W2129702476 @default.
- W1833159727 cites W2132836791 @default.
- W1833159727 cites W2133480941 @default.
- W1833159727 cites W2136274459 @default.
- W1833159727 cites W2136541538 @default.
- W1833159727 cites W2136947191 @default.
- W1833159727 cites W2138442302 @default.
- W1833159727 cites W2143626441 @default.
- W1833159727 cites W2146149414 @default.
- W1833159727 cites W2149884610 @default.
- W1833159727 cites W2151000726 @default.
- W1833159727 cites W2156100905 @default.
- W1833159727 cites W2158780936 @default.
- W1833159727 cites W2163404991 @default.
- W1833159727 cites W2163921360 @default.