Fabrication of human oral mucosal epithelial cell sheets for treatment of esophageal ulceration by endoscopic submucosal dissection.
BACKGROUND
Esophageal stenosis is one of the major complications of aggressive endoscopic resection. Tissue-engineered epithelial cell grafts have demonstrated effectiveness in promoting re-epithelialization and suppressing inflammation causing esophageal scarring and stenosis after endoscopic submucosal dissection (ESD) in an animal model.


OBJECTIVE
To confirm the reproducibility and efficacy of a human oral mucosal epithelial cell (hOMEC) sheet cultured on temperature-responsive surface in conformity with Good Manufacturing Practice guidelines.


METHODS
A preclinical study.


METHODS
Good Manufacturing Practice grade cell-processing center, animal laboratory.


METHODS
Canine esophageal ulcer models, which were made by ESD.


METHODS
Oral mucosal specimens were obtained from 7 healthy volunteers.


METHODS
Fabricated and transplanted hOMEC sheets were subjected to histological analysis.


RESULTS
The reproducibility of the fabrication of hOMEC sheets was confirmed. In this method, animal-derived materials such as 3T3 feeder layer and fetal bovine serum were successfully excluded from the culture condition. Furthermore, the environment of the culture room and safety cabinet in the cell-processing center was maintained for obtaining sterility assurances during the fabrication. Transplanted hOMEC sheets after ESD were observed to graft onto canine esophageal ulcer surfaces.


CONCLUSIONS
Small number of subjects, animal model.


CONCLUSIONS
Cultured hOMEC sheets were fabricated without animal-derived materials and demonstrated efficacy as a medical device that promotes re-epithelialization of an esophageal ulcer after ESD.
Takagi
Ryo
R
Institute of Advanced Biomedical Engineering and Science, Tokyo Women’s Medical University, Tokyo, Japan.
Murakami
Daisuke
D
Kondo
Makoto
M
Ohki
Takeshi
T
Sasaki
Ryo
R
Mizutani
Manabu
M
Yamato
Masayuki
M
Nishida
Kohji
K
Namiki
Hideo
H
Yamamoto
Masakazu
M
Okano
Teruo
T
D000818:Animals; D004195:Disease Models, Animal; D004210:Dissection / Q000379:methods*; D004285:Dogs; D004847:Epithelial Cells / Q000473:pathology / Q000637:transplantation*; D004935:Esophageal Diseases / Q000473:pathology / Q000601:surgery*; D004945:Esophagoscopy / Q000379:methods*; D006801:Humans; D009061:Mouth Mucosa / Q000637:transplantation*; D023822:Tissue Engineering / Q000379:methods*; D014456:Ulcer / Q000473:pathology / Q000601:surgery*