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Significant efforts have been made towards the development of a tissue engineered heart valve (TEHV) for the treatment of congenital valvular disorders. While progress has been made, widespread clinical translation of the TEHV has not yet been realized. Regulatory concerns have contributed to this, especially with U.S. markets. The review seeks to identify those challenges, many of which could be mitigated through the implementation of TEHV processing within the clinical environment. However, traditional approaches to heart valve tissue engineering are often not conducive to application in such a setting due to challenges inherent to the seeding strategies themselves, as well as deficiencies in the bioreactor systems used to implement those strategies. Here, we present an alternative strategy that utilizes a novel bioreactor system to circumvent many of the issues that have hindered the translation of the TEHV for the laboratory to bedside. |
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