The science of regenerative medicine aims to replace living tissues. Translational scientific advances offer great promise in many areas of medicine especially those presented by our aging population. Novel interdisciplinary approaches to health care such as tissue engineering have the potential to improve the surgical outcomes of tissue repair through the collaboration of biologists, bioengineers, surgeons, patient groups, and commercial interests.
Understanding the cellular and molecular responses of cells to enable in vitro evaluation of biocompatible scaffolds for use in tissue engineering is essential. Providing a scaffold that encourages appropriate cell attachment, growth, and ultimately tissue regeneration could improve the clinical outcomes from injuries and diseases. Cellular and molecular responses of cells grown in traditional 2-dimensional tissue culture plates compared to simple 3-dimensional cultures can be used to identify mechano-sensors, mechanically-mediated switches in cell commitment, focal adhesions, and cell-to-cell communication to better understand the biocompatibility of potential tissue engineering products. Much time and expense can be saved by such in vitro evaluation of biomaterials prior to embarking on in vivo studies.
The FDA receives millions of reports of medical device failure annually suggesting that pre-clinical assessment of these novel products is shaky. The majority of adverse events are related to immune rejection, thus a greater understanding of how these materials interact with the immune system is imperative, with a focus on the macrophage response being particularly important. Uptake of in vitro immune response assessment will allow for substantial reductions in experimental time and resources, including unnecessary and unethical animal use, with a simultaneous decrease in inappropriate biomaterials reaching the clinic.
Regenerative medicine can include the use of growth factors as well as cell and gene therapies, however recently, global stem cell opportunities for unregulated therapies have been challenged. This improvement in bench-to-bedside safety is paramount to reducing patient harm.