title: Fabrication and validation of autologous human oral mucosal epithelial cell sheets to prevent stenosis after esophageal endoscopic submucosal dissection.
abstract: OBJECTIVE
  Human oral mucosal epithelial cells derived from 7 healthy volunteer donors were cultured in a clean room in a cell-processing center (CPC) according to good manufacturing practice guidelines. Cell culture and fabricated transplantable epithelial cell sheets were validated for treating ulcers after endoscopic mucosal dissection.
  
  
  METHODS
  The clonal growth and morphology of the human oral mucosal epithelial cells seeded on temperature-responsive surfaces were observed. During the cultivation, sterilization tests were performed to validate the environment in the CPC. To validate the purity and morphology of fabricated epithelial cell sheets, cell sheets harvested from temperature-responsive surfaces by temperature reduction were examined by histology and flow cytometry.
  
  
  RESULTS
  Human oral mucosal epithelial cells were successfully cultured and harvested as continuous cell sheets from temperature-responsive culture inserts without any animal-derived materials. During the cultivations, the sterile environment in the CPC was confirmed. The results of histological and flow cytometry analysis showed the high reproducibility of stratification and the purity of the fabricated human oral mucosal epithelial cell sheets.
  
  
  CONCLUSIONS
  The method for fabricating epithelial cell sheets shown in this study was suitable for the validation for clinical trials and suggested usability of the fabricated cell sheets.
authors: Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University and Global Center of Excellence, Japan.
authors: Ryo
authors: R
authors: Takagi
authors: Masayuki
authors: M
authors: Yamato
authors: Daisuke
authors: D
authors: Murakami
authors: Makoto
authors: M
authors: Kondo
authors: Takeshi
authors: T
authors: Ohki
authors: Ryo
authors: R
authors: Sasaki
authors: Kohji
authors: K
authors: Nishida
authors: Hideo
authors: H
authors: Namiki
authors: Masakazu
authors: M
authors: Yamamoto
authors: Teruo
authors: T
authors: Okano
mesh_terms: D000328:Adult; D000818:Animals; D002478:Cells, Cultured; D004847:Epithelial Cells / Q000502:physiology / Q000637:transplantation*; D004940:Esophageal Stenosis / Q000209:etiology / Q000517:prevention & control*; D004945:Esophagoscopy / Q000009:adverse effects*; D004947:Esophagus / Q000601:surgery*; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000502:physiology / Q000637:transplantation*; D013552:Swine; D013696:Temperature; D023822:Tissue Engineering; D014182:Transplantation, Autologous; D014456:Ulcer / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult