Voluntary Guidance for the Development of Tissue-Engineered Products

Abstract

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.

Modulation of Hepatocarcinoma Cell Morphology and Activity by Parylene-C Coating on PDMS

“…Due to the complex role of these interactions in regulating many physiological processes, novel approaches dedicated to controlling ECM structure on culture substratum are required to better understand how the microenvironment influences cell morphology and activity. Therefore, it is of first importance to develop future standardized tissue-engineered platforms that take into account the sourcing of cells and tissues [9].…”

Influence of Sp1/Sp3 Expression on Corneal Epithelial Cells Proliferation and Differentiation Properties in Reconstructed Tissues

“…They are widely used, either alone or in combination with synthetic biomaterials, in the production of tissue-engineered substitutes, a very active emerging field of medical research (reviewed in Ref. 1). Indeed, new synthetic or bioengineered substitutes capable of upregulating or downregulating biological responses at the tissue-substitute interface are starting to reach clinical application.…”

Quality control of cultured tissues requires tools for quantitative analyses of heterogeneous features developed in manufacturing process

“…For repairing articular cartilage defects, the innovative techniques based on tissue engineering have been developed, being now at a practical stage of clinical application by means of grafting in vitro cultured products (Wakitani et al 1989;Omstead et al 1998;du Moulin and Morohashi 2000). Figure 4 shows the representative process of autologous production of cultured cartilage, which consists mainly of planar (monolayer) growth for cell expansion and spatial growth for tissue functioning.…”