Voluntary Guidance for the Development of Tissue-Engineered Products
| Autor: | Ross Tubo, Deirdre D. Maxted, Gary C. Du Moulin, James Davis, Frank T. Gentile, Daniel R. Omstead, Lynn G. Baird, Lisa Christenson |
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| Rok vydání: | 1998 |
| Předmět: |
Male
Quality Control Engineering Quality Assurance Health Care media_common.quotation_subject Transplantation Heterologous Biomedical Engineering Biocompatible Materials Prosthesis Design Materials Testing Animals Humans Transplantation Homologous Quality (business) Product (category theory) Set (psychology) Cells Cultured media_common Bioprosthesis Biological Products Clinical Trials as Topic Tissue engineered business.industry General Engineering Prostheses and Implants Medical research Product type Tissue Donors Biotechnology Transplantation Risk analysis (engineering) Communicable Disease Control Female Artificial Organs Safety business Quality assurance |
| Zdroj: | Tissue Engineering. 4:239-266 |
| ISSN: | 1557-8690 1076-3279 |
| DOI: | 10.1089/ten.1998.4.239 |
| Popis: | Tissue Engineering is an emerging field of medical research in which there is tremendous activity. Many of these products rely on the use of a cellular component co-formulated with a natural or synthetic biomaterial. At this time, though, there are no consensus safety or efficacy standards for tissue-engineered products. We describe general approaches for assessment of the safety and efficacy of cell-based tissue-engineered products which will lead to reliable medical products for human use. This article provides a general summary of the factors that should be considered in the design and development of cell- and tissue-based products. Seven areas are considered: cell and tissue sourcing; cell and tissue characterization; biomaterials testing; quality assurance; quality control; and nonclinical testing and clinical evaluation. Factors relevant to these areas have been discussed to provide a set of recommendations on which development of products can be standardized. Where relevant, the discussion has been separated in each area to issues that are independent or dependent on cell source. Also, examples are provided of how these guidelines would be applied to two product types that represent somewhat extreme ends of the spectrum for tissue engineering applications. The first example is a product whose mechanism of action is to provide locally-acting structural repair or enhancement in vivo. The second example is a product whose mechanism of action involves systemically distributed physiologically or pharmacologically active products. In general, we have limited the discussion of product types to those that are implanted into the patient for relatively long periods of time. We believe that adoption of these voluntary guidelines would lead to products that are more consistent in quality and performance as well as more rapidly developed. |
| Databáze: | OpenAIRE |
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