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Tissue Engineering and Regenerative Medicine: Role of Toxicologic Pathologists for an Emerging Medical TechnologyTengion, Inc., Winston-Salem, North Carolina, USA Correspondence: Address correspondence to: Belinda J. Wagner, Tengion, Inc., 3929 Westpoint Blvd., Suite G, Winston-Salem, NC 27103; e-mail: belinda.wagner{at}tengion.com. Tissue Engineering Regenerative Medical (TERM) products are a new technology currently in human clinical testing for a variety of unmet medical needs involving tissue and organ dysfunction and failure. Safety evaluation of TERM products overlaps 3 established product paradigms: pharmaceuticals (biologically active substances), transplantation (cells or tissue), and devices (biomaterials). As TERM products recapitulate organ or tissue structure and function with unique biological activity and characteristics, they require new preclinical paradigms to bring TERM products through to clinical trials. Establishing TERM-product safety programs requires broad-based knowledge of tissue and organ homeostasis, regenerative biology, and translational medicine to design new preclinical paradigms. Therefore, toxicologic pathologists have a compelling scientific role in evaluating TERM products, characterizing tissue responses, and helping distinguish optimal (regeneration) from deficient or incomplete outcomes indicative of substandard functionality (repair). As new-tissue engineering and regenerative medical technologies develop for tissue and organ regeneration, the toxicologic pathologist will be asked to develop novel testing, reevaluate established toxicologic diagnostic criteria, and reinterpret tissue responses that may extend beyond current standards.
Key Words: Toxicologic pathology • safety assessment • preclinical research and development • organ regeneration • pathobiology • transplant biology • medical devices • animal models Abbreviations: BLA, biological license application • CFR, Code of Federal Regulations • FDA, Food and Drug Administration • GLP, good laboratory practices • GMP, good manufacturing practices • IDE, investigative device exemption • IND, investigational new drug • ISO, International Organization for Standardization • MRI, magnetic resonance imaging • NDA, new drug application • PHS, public health services • PMA, premarketing authorization • TERM, Tissue Engineering Regenerative Medical • TERMIS, Tissue Engineering and Regenerative Medicine International Society • USP, United States Pharmacopeia
Toxicologic Pathology, Vol. 36, No. 1,
92-96 (2008) |
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