The Importance Of Tissue Engineering And Human Clinical Trials

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Tissue engineering has been an opportunity to restore the human condition from wounded to whole through the combination of biological, biochemical, and biomechanical concepts. Unlike traditional transplantation, tissue engineering and regenerative medicine uses a patient’s own cells to fabricate new tissues which are then grafted back into his or her body. Of course, the goal is to apply the practices in the lab to the general public and to develop a new and more effective means to treat patients with severe tissue loss and/or organ failure. Each innovation requires a certain series of steps and regulations, from laboratory study to animal testing to human clinical trials. Unfortunately, a majority of tissue engineering trials fail to translate from lab to hospital because of a variety of issues, especially during clinical trials. According to Lanza et al., “Over the last decade, we have seen a number of tissue-engineered products that have either been abandoned following Phase I/II clinical trials, or have failed in Phase III clinical testing.” The relatively high cost of these technologies and the lengthy experimentation lead to the question of how clinical trials are to be funded. For cases involving Investigational New Drugs (INDs), the U.S. Food and Drug Administration (FDA) allows sponsors of a research project to charge patients for the administration of investigational products during clinical studies. Traditionally, funding for clinical trials is provided by
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