Learning Objectives:
Introduction: Recurrence of cholesteatoma is mainly caused by poor mucosal regeneration in the middle ear cavity and mastoid cavity. If middle ear mucosa can be preserved and the rapid postoperative regeneration of mucosa on the exposed bone surface can be achieved after middle ear surgery, surgical treatment for otitis media including cholesteatoma can be potentially improved. Conventional canal wall up tympanoplasty often results in a lack of mucosal regeneration in the resected area of the mastoid cavity. We developed a novel method combining canal wall up tympanoplasty and autologous epithelial cell sheet transplantation for postoperative regeneration of the middle ear mucosa.
Methods: We obtained the approval of the ethics committee of our institution and the Ministry of Health, Labor, and Welfare. We endoscopically removed an approximately 10 × 10-mm2 nasal mucosal tissue from her inferior concha. Tissue-engineered autologous nasal mucosal epithelial cell sheets were fabricated by culturing the harvested cells using temperature-responsive culture dishes for 26 days in an aseptic environment in a good manufacturing practice (GMP)-compliant cell processing center (CPC). The cultivated cell sheets were transplanted, during canal wall up tympanoplasty, onto the exposed bony surface of the attic of the tympanic and mastoid cavities where the mucosa was lost.
Results: During the cultivation, the sterile environment in the CPC was confirmed. Autologous cell sheets were successfully transplanted to human middle ear. We have already clinically applied cell sheets to treat 5 patients of middle ear cholesteatoma. All patients showed a favorable postoperative course, with no adverse events or complications.
Conclusion: This is a first-in-man study in the world that the cultured cells were transplanted to the human ear. This novel technology of transplantation might be an effective alternative to the surgical operation on intractable otitis media in the near future.
