Endoscopic cell sheet transplantation device developed by using a 3-dimensional printer and its feasibility evaluation in a porcine model

Background To prevent severe esophageal stenosis after aggressive endoscopic submucosal dissection (ESD), our group previously reported an efficient treatment using cell sheets that had been fabricated from patient cells. However, this transplantation procedure had not been easy for every endoscopist and needed to be improved to derive the full effect of epithelial cell sheets. Objective To develop an endoscopic device that enables easy and effective cell sheet transplantation and to evaluate its performance and clinical feasibility. Design Animal study. Setting Animal experimentation laboratory. Intervention Three pigs underwent circumferential esophageal ESD while under general anesthesia. A total of 12 cell sheets were endoscopically transplanted to the ESD site; 6 cell sheets were transplanted by using an endoscopic device that we developed, and 6 cell sheets were transplanted by using the conventional method. Main Outcome Measurements Procedure time, transplanted area on the ESD site, transplantation success rate, and monitoring of adverse events or incidents. Results The device allowed successful transplantation of all cell sheets with a shorter procedure time than with the conventional method (4.8 ± 0.8 minutes vs 13.3 ± 5.7 minutes, respectively) ( P = .005) and onto a larger area (111.3 ± 56.3 mm2 vs 41.8 ± 4.2 mm2 , respectively) ( P = .023) with a higher success rate (100% vs 83%, respectively). No adverse incidents were monitored in each method. Limitations Animal study, small sample. Conclusion A newly designed endoscopic cell sheet transplantation device would be useful.