PulmoStent: In Vitro to In Vivo Evaluation of a Tissue Engineered Endobronchial Stent
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Currently, there is no optimal treatment available for end stage tumour patients with airway stenosis. The PulmoStent concept aims on overcoming current hurdles in airway stenting by combining a nitinol stent with a nutrient-permeable membrane, which prevents tumour ingrowth. Respiratory epithelial cells can be seeded onto the cover to restore mucociliary clearance. In this study, a novel hand-braided dog bone stent was developed, covered with a polycarbonate urethane nonwoven and mechanically tested. Design and manufacturing of stent and cover were improved in an iterative process according to predefined requirements for permeability and mechanical properties and finally tested in a proof of concept animal study in sheep for up to 24 weeks. In each animal two stents were implanted, one of which was cell-seeded by endoscopic spraying in situ. We demonstrated the suitability of this membrane for our concept by glucose transport testing and in vitro culture of respiratory epithelial cells. In the animal study, no migration occurred in any of the twelve stents. There was only mild granulation tissue formation and tissue reaction; no severe mucus plugging was observed. Thus, the PulmoStent concept might be a step forward for palliative treatment of airway stenosis with a biohybrid stent device.
KeywordsTissue engineering Stent development Airway stenting Animal trial
We thank the Institute of Laboratory Animal Science of the RWTH Aachen University Hospital headed by Univ.-Prof. Dr. med. René H. Tolba especially Dr. med. vet. Kira Scherer for her advice and support before and during the animal experiments and Ms. Lisa Liebenstund, Ms. Dunja Sieger and Mr. Thaddäus Stopinski for their excellent work during the animal experiments. Furthermore, we thank Ludovic Wiszniewski from Epithelix Sárl in Geneva, Switzerland for cooperation and Ms. Irina Appel for technical assistance with tissue sectioning. This work was supported by the European Union’s Seventh Framework Program (FP7/2007-2013 under Grant Agreement N° NMP3-SL-2012-280915).
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