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A distinguishing characteristic of regenerative medicine is that it has the potential to cure disease through repair or replacement of damaged or failing tissues.

Regenerative medicine/tissue engineering is a rapidly growing multidisciplinary field involving the life, physical and engineering sciences that seeks to develop functional cell, tissue, and organ substitutes to repair, replace or enhance biological function that has been lost due to congenital abnormalities, injury, disease, or aging.

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It includes both the regeneration of tissues in vitro for subsequent implantation in vivo as well as regeneration directly in vivo. In addition to having a therapeutic application, tissue engineering can have a diagnostic application where the engineered tissue is used as a biosensor. Engineered tissues can also be used for the development of drugs including screening for novel drug candidates, identifying novel genes as drug targets, and testing for drug metabolism, uptake, and toxicity.



Regenerative medicine/tissue engineering research includes the following areas:  

1. Development of novel biomaterials/scaffolds
   Including biomaterials that are designed to direct the growth, differentiation, and organization of cells in the process of forming functional tissue by providing physical, chemical, and mechanical cues.
   
2. Identification of optimal cell sources
   Including the acquisition of appropriate cells for particular applications from a variety of potential sources such as autologous, allogeneic, syngeneic, and xenogeneic cells, stem and progenitor cells, and genetically engineered cells.  Also included are methods for the directed proliferation and differentiation of cells and immunological manipulation.
3. Biomolecules
   Including angiogenic factors, growth factors, differentiation factors, and morphogens.
4. Engineering Methods and Design
   Including 2-D cell expansion/scale-up, 3-D tissue growth, cell encapsulation, bioreactor technology, vascularization and mass transport issues, preservation, storage, and shipping of cells and engineered tissues, and biomechanical property requirements of engineered tissues as well as mechanical signals regulating function.
5. Functional assessment of regenerated/engineered tissues
   Including new imaging tools for real-time, non-destructive, in vitro and in vivo assessment of function, efficacy and safety.
6. Informatics as applied to tissue engineering
   Including the application of tools and information from many areas of informatics to the design and characterization of engineered tissues. This would include gene and protein expression data analysis and data mining tools, quantitative cellular image analysis, multi-scale modeling of engineered tissues, digital tissue manufacturing, and digital quality assurance systems.

This definition is used for coding purposes. Source:  National Institute of Biomedical Imaging and Bioengineering, June 2004.