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NIH Definition of Tissue Engineering/Regenerative Medicine

Tissue engineering / regenerative medicine is an emerging multidisciplinary field involving biology, medicine, and engineering that is likely to revolutionize the ways we improve the health and quality of life for millions of people worldwide by restoring, maintaining, or enhancing tissue and organ function. In addition to having a therapeutic application, where the tissue is either grown in a patient or outside the patient and transplanted, tissue engineering can have diagnostic applications where the tissue is made in vitro and used for testing drug metabolism and uptake, toxicity, and pathogenicity. The foundation of tissue engineering/regenerative medicine for either therapeutic or diagnostic applications is the ability to exploit living cells in a variety of ways. Tissue engineering research includes the following areas:

1) Biomaterials: including novel biomaterials that are designed to direct the organization, growth, and differentiation of cells in the process of forming functional tissue by providing both physical and chemical cues.

2) Cells: including enabling methodologies for the proliferation and differentiation of cells, acquiring the appropriate source of cells such as autologous cells, allogeneic cells, xenogeneic cells, stem cells, genetically engineered cells, and immunological manipulation.

3) Biomolecules: including angiogenic factors, growth factors, differentiation factors and bone morphogenic proteins

4) Engineering Design Aspects: including 2-d cell expansion, 3-d tissue growth, bioreactors, vascularization, cell and tissue storage and shipping (biological packaging).

5) Biomechanical Aspects of Design: including properties of native tissues, identification of minimum properties required of engineered tissues, mechanical signals regulating engineered tissues, and efficacy and safety of engineered tissues

6) Informatics to support tissue engineering: gene and protein sequencing, gene expression analysis, protein expression and interaction analysis, quantitative cellular image analysis, quantitative tissue analysis, in silico tissue and cell modeling, digital tissue manufacturing, automated quality assurance systems, data mining tools, and clinical informatics interfaces.

Stem cell research - Includes research that involves stem cells, whether from embryonic, fetal, or adult sources, human and non-human. It should include research in which stem cells are isolated, derived or cultured for purposes such as developing cell or tissue therapies, studying cellular differentiation, research to understand the factors necessary to direct cell specialization to specific pathways, and other developmental studies. It should not include transgenic studies, gene knock-out studies nor the generation of chimeric animals.



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