Objective: The bioengineering of tissues and organs, sometimes called tissue engineering and at other times regenerative medicine, is emerging as a science, as a technology, and as an industry. The goal is the repair, replacement, and/or the regeneration of tissues and organs. The objective of this paper is to identify and discuss the major issues that have become apparent.
Results: One of the critical issues is that of cell source, i.e. what will be the source of the cells to be employed? Another critical issue is the development of approaches for the fabrication of substitute tissues/organs and/or vehicles for the delivery of biological active molecules for use in the repair/regeneration of tissues. A third critical issue, one very much related to cell source, is that of immune acceptance. In addition, there are technological hurdles; there are additional issues such as the scale-up of manufacturing processes and the preservation of living-cell products for off-the-shelf availability. Although the initial products have been superficially applied skin substitutes, as this fledgling industry continues to evolve, it is beginning to focus on a wider range of more invasive and complicated products. From a public health perspective, the real opportunity may be in addressing chronic diseases, as well as the transplantation crisis (i.e. the tremendous disparity between patient need for vital organs and donor availability) and, equally important is the challenge of neural repair.
Conclusion: These are the grand challenges, and the scientific community, business/private sector, and federal government must mobilize itself together in this emerging area to translate the benchtop science to the patient bedside.