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<p>Refractory anastomotic restenosis following surgery for congenital esophageal atresia (CEA) or congenital esophageal stenosis (CES) remains a serious complication in pediatric surgery. Repeated endoscopic balloon dilatation (EBD) under general anesthesia often impairs growth, feeding function, and overall quality of life (QOL). We have developed a regenerative therapy using autologous oral mucosal epithelial cell sheets. This study aimed to evaluate the long-term safety and efficacy of epithelial cell sheet transplantation for refractory esophageal restenosis in pediatric patients. Between 2018 and 2024, epithelial cell sheet transplantation was performed immediately after EBD in six patients (aged 8–41&#xa0;years) with refractory anastomotic restenosis following surgery for CEA and/or CES. The cell sheets were fabricated by culturing oral mucosal tissue harvested from each patient in temperature-responsive culture dishes with autologous serum, then non-enzymatically detached and endoscopically transplanted onto the stricture site. Postoperatively, patients were monitored for 48&#xa0;weeks to assess EBD frequency, endoscopic patency, dietary status, and adverse events. In later cases, evaluation for eosinophilic esophagitis (EoE) was also performed. No serious adverse events were observed in any of the patients, confirming the safety of the procedure. One patient showed only temporary improvement and required surgical reconstruction. In four patients, long-term patency was achieved without the need for additional EBD, with the longest recurrence-free period lasting up to five years. Swallowing function, dietary intake, and overall QOL markedly improved in all of these cases. Notably, two patients had concomitant EoE, suggesting that inflammation control may influence therapeutic outcomes. Transplantation of autologous oral mucosal epithelial cell sheets appeared to promote safe and sustained epithelial regeneration and functional recovery in pediatric patients with refractory esophageal strictures. Combining intervention before irreversible fibrotic remodeling is established with control of inflammation and optimization of the local environment to support engraftment may further enhance therapeutic efficacy.</p><p> Trial registration: UMIN, UMIN000034566, registered 19 October 2018, <a href="https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039393">https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039393</a>. jRCT, jRCTb030190278, registered 31 March 2020, <a href="https://jrct.mhlw.go.jp/en-latest-detail/jRCTb030190278">https://jrct.mhlw.go.jp/en-latest-detail/jRCTb030190278</a>.</p>

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Sustained efficacy and long-term outcomes of autologous oral mucosal epithelial cell sheet transplantation for pediatric esophageal anastomotic restenosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月1日

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  • Yasushi Fuchimoto,
  • Yuki Yamamoto,
  • Akihiro Fujino,
  • Naoki Shimojima,
  • Akihiro Yoneda,
  • Tetsuya Ishimaru,
  • Nobutaka Isogawa,
  • Katsuhiro Arai,
  • Takako Yoshioka,
  • Makoto Abe,
  • Nobuo Kanai,
  • Ryo Takagi,
  • Masanori Maeda,
  • Akihiro Umezawa

摘要

Refractory anastomotic restenosis following surgery for congenital esophageal atresia (CEA) or congenital esophageal stenosis (CES) remains a serious complication in pediatric surgery. Repeated endoscopic balloon dilatation (EBD) under general anesthesia often impairs growth, feeding function, and overall quality of life (QOL). We have developed a regenerative therapy using autologous oral mucosal epithelial cell sheets. This study aimed to evaluate the long-term safety and efficacy of epithelial cell sheet transplantation for refractory esophageal restenosis in pediatric patients. Between 2018 and 2024, epithelial cell sheet transplantation was performed immediately after EBD in six patients (aged 8–41 years) with refractory anastomotic restenosis following surgery for CEA and/or CES. The cell sheets were fabricated by culturing oral mucosal tissue harvested from each patient in temperature-responsive culture dishes with autologous serum, then non-enzymatically detached and endoscopically transplanted onto the stricture site. Postoperatively, patients were monitored for 48 weeks to assess EBD frequency, endoscopic patency, dietary status, and adverse events. In later cases, evaluation for eosinophilic esophagitis (EoE) was also performed. No serious adverse events were observed in any of the patients, confirming the safety of the procedure. One patient showed only temporary improvement and required surgical reconstruction. In four patients, long-term patency was achieved without the need for additional EBD, with the longest recurrence-free period lasting up to five years. Swallowing function, dietary intake, and overall QOL markedly improved in all of these cases. Notably, two patients had concomitant EoE, suggesting that inflammation control may influence therapeutic outcomes. Transplantation of autologous oral mucosal epithelial cell sheets appeared to promote safe and sustained epithelial regeneration and functional recovery in pediatric patients with refractory esophageal strictures. Combining intervention before irreversible fibrotic remodeling is established with control of inflammation and optimization of the local environment to support engraftment may further enhance therapeutic efficacy.

Trial registration: UMIN, UMIN000034566, registered 19 October 2018, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039393. jRCT, jRCTb030190278, registered 31 March 2020, https://jrct.mhlw.go.jp/en-latest-detail/jRCTb030190278.