Abstract
Objectives:
The likelihood of recurrent retraction and adhesion of newly formed tympanic membrane is high when normal middle ear mucosa is extensively lost during intractable middle surgery. If rapid postoperative regeneration of the mucosa on the exposed bone surface can be achieved, prevention of recurrent tympanic membrane adhesion and cholesteatoma formation can be expected. The aim of this study was to develop a new method to transplant autologous cell-sheets to promote postoperative regeneration of the middle ear mucosa.
Methods:
We harvested 10-by-10-mm specimens of inferior turbinate mucosal tissue from the patient with acquired middle ear cholesteaoma. Tissue-engineered epithelial-cell sheets were fabricated ex vivo by culturing harvested cells for 3 weeks on temperature-responsive culture dishes in a cell-processing center (CPC) according to good manufacturing practice guidelines. After canal wall up tympanoplasty with mastoidectomy had been performed, sheets of cultured autologous cells that had been harvested with a simple reduced-temperature treatment were transplanted directly into the exposed bone surface of middle ear cavity from which normal mucosa had been absent.
Results:
During the cultivation, the sterile environment in the CPC was confirmed. Autologous cell sheets were successfully transplanted to human middle ear.
Conclusions:
This is the first clinical study approved from the Ministry of Health, Labour and Welfare in Japan. Furthermore this is a first-in-man study in the world in which 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.
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