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Case Report

Early Clinical Outcomes of the First Commercialized Human Autologous Ex Vivo Cultivated Oral Mucosal Epithelial Cell Transplantation for Limbal Stem Cell Deficiency: Two Case Reports and Literature Review

by
Hiroshi Toshida
1,*,
Tomoto Kasahara
1,
Masamichi Kiriyama
1,
Yuma Iwasaki
1,
Jobu Sugita
1,
Kohei Ichikawa
1,
Toshihiko Ohta
1 and
Katsumi Miyahara
2
1
Department of Ophthalmology, Juntendo University Shizuoka Hospital, Shizuoka 410-2211, Japan
2
Laboratory of Morphology and Image Analysis, Biomedical Research Core Facilities, Juntendo University Graduate School of Medicine, Tokyo 113-0033, Japan
*
Author to whom correspondence should be addressed.
Int. J. Mol. Sci. 2023, 24(10), 8926; https://doi.org/10.3390/ijms24108926
Submission received: 30 April 2023 / Revised: 14 May 2023 / Accepted: 16 May 2023 / Published: 18 May 2023
(This article belongs to the Special Issue Dry Eye and Ocular Surface Disorders 4.0)
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Abstract

The first product in the world for ex vivo cultivated oral mucosal epithelial cell transplantation (COMET) to treat limbal stem cell deficiency (LSCD), named Ocural®, was launched in June 2021 in Japan. COMET was performed on two patients, including the first case in the post-marketing phase of Ocural®. Pathological and immunohistochemical examinations were also carried out using specimens obtained before and after COMET and the spare cell sheet. In case 1, the ocular surface remained free from epithelial defects for approximately six months. In case 2, although defect of the cornea-like epithelia was observed after COMET for one month, it was resolved after the insertion of lacrimal punctal plugs. In case 1, adjuvant treatment was interrupted due to an accident during the second month after COMET, resulting in conjunctival ingrowth and corneal opacity. Eventually, a lamellar keratoplasty was required at six months after COMET. Immunohistochemistry revealed the presence of markers for stem cells (p63, p75), proliferation (Ki-67), and differentiation (Keratin-3, -4, and -13) in both the cornea-like tissue after COMET and a cultivated oral mucosal epithelial cell sheet. In conclusion, Ocural® can be accomplished without major complications, and the stem cells derived from oral mucosa might be successfully engrafted.
Keywords: limbal stem cell deficiency; cultivated oral mucosal epithelial cell transplantation; stem cell; regeneration therapy; COMET; Ocural® limbal stem cell deficiency; cultivated oral mucosal epithelial cell transplantation; stem cell; regeneration therapy; COMET; Ocural®

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MDPI and ACS Style

Toshida, H.; Kasahara, T.; Kiriyama, M.; Iwasaki, Y.; Sugita, J.; Ichikawa, K.; Ohta, T.; Miyahara, K. Early Clinical Outcomes of the First Commercialized Human Autologous Ex Vivo Cultivated Oral Mucosal Epithelial Cell Transplantation for Limbal Stem Cell Deficiency: Two Case Reports and Literature Review. Int. J. Mol. Sci. 2023, 24, 8926. https://doi.org/10.3390/ijms24108926

AMA Style

Toshida H, Kasahara T, Kiriyama M, Iwasaki Y, Sugita J, Ichikawa K, Ohta T, Miyahara K. Early Clinical Outcomes of the First Commercialized Human Autologous Ex Vivo Cultivated Oral Mucosal Epithelial Cell Transplantation for Limbal Stem Cell Deficiency: Two Case Reports and Literature Review. International Journal of Molecular Sciences. 2023; 24(10):8926. https://doi.org/10.3390/ijms24108926

Chicago/Turabian Style

Toshida, Hiroshi, Tomoto Kasahara, Masamichi Kiriyama, Yuma Iwasaki, Jobu Sugita, Kohei Ichikawa, Toshihiko Ohta, and Katsumi Miyahara. 2023. "Early Clinical Outcomes of the First Commercialized Human Autologous Ex Vivo Cultivated Oral Mucosal Epithelial Cell Transplantation for Limbal Stem Cell Deficiency: Two Case Reports and Literature Review" International Journal of Molecular Sciences 24, no. 10: 8926. https://doi.org/10.3390/ijms24108926

APA Style

Toshida, H., Kasahara, T., Kiriyama, M., Iwasaki, Y., Sugita, J., Ichikawa, K., Ohta, T., & Miyahara, K. (2023). Early Clinical Outcomes of the First Commercialized Human Autologous Ex Vivo Cultivated Oral Mucosal Epithelial Cell Transplantation for Limbal Stem Cell Deficiency: Two Case Reports and Literature Review. International Journal of Molecular Sciences, 24(10), 8926. https://doi.org/10.3390/ijms24108926

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