June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Efficacy and Safety Evaluation of Cell-Injection Therapy using Cultivated Human Corneal Endothelial Cells
Author Affiliations & Notes
  • Noriko Koizumi
    Biomedical Engineering, Doshisha University, Kyotanabe City, Japan
    Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan
  • Naoki Okumura
    Biomedical Engineering, Doshisha University, Kyotanabe City, Japan
    Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan
  • Takashi Shiina
    Molecular Life Sciences, Tokai University School of Medicine, Isehara, Japan
  • Shingo Suzuki
    Molecular Life Sciences, Tokai University School of Medicine, Isehara, Japan
  • Shinichiro Nakamura
    Research Center for Animal Life Science, Shiga University of Medical Science, Otsu, Japan
  • Yuji Sakamoto
    Biomedical Engineering, Doshisha University, Kyotanabe City, Japan
  • Kenta Yamasaki
    Biomedical Engineering, Doshisha University, Kyotanabe City, Japan
  • Morio Ueno
    Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan
  • Junji Hamuro
    Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan
  • Shigeru Kinoshita
    Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan
  • Footnotes
    Commercial Relationships Noriko Koizumi, None; Naoki Okumura, None; Takashi Shiina, None; Shingo Suzuki, None; Shinichiro Nakamura, None; Yuji Sakamoto, None; Kenta Yamasaki, None; Morio Ueno, Senju Pharmaceutical Co (P), Santen Pharmaceutical Co (P); Junji Hamuro, None; Shigeru Kinoshita, Senju Pharmaceutical Co (P), Santen Pharmaceutical Co (P), Otsuka Pharmaceutical Co (C), Alcon (R), AMO (R), HOYA (R)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 2201. doi:
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      Noriko Koizumi, Naoki Okumura, Takashi Shiina, Shingo Suzuki, Shinichiro Nakamura, Yuji Sakamoto, Kenta Yamasaki, Morio Ueno, Junji Hamuro, Shigeru Kinoshita; Efficacy and Safety Evaluation of Cell-Injection Therapy using Cultivated Human Corneal Endothelial Cells. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2201.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To investigate the efficacy and safety of corneal endothelial reconstruction by a cell-injection therapy using cultivated human corneal endothelial cells (HCECs) in a corneal endothelial dysfunction monkey model.

Methods: The corneal endothelium of 8 eyes of 8 monkeys was intensively scraped off up to the peripheral area to create a corneal endothelial dysfunction model. A 5.0 x 105 amount of cultivated HCECs, labeled by fluorescein marker DiI, was then injected into the anterior chamber of those 8 eyes. Slit-lamp examinations and intraocular pressure (IOP) measurements of the cell-injected eyes were then performed on postoperative day 1 through day 14. Fourteen days after cell-injection, 31 primary organs were harvested from each animal after euthanasia and were set aside for histological examination. To examine the ectopic deposition of donor HCECs systemically, tissue sections obtained from those 31 organs were examined by fluorescein microscopy to search for DiI-positive donor cells. Genomic DNA was then extracted from tissue samples of 31 organs and examined by polymerase chain reaction (PCR) using human-specific primers to elucidate if it was contaminated with any donor-HCEC-derived DNA.

Results: Seven days after cell-injection, 6 of the 8 eyes (75%) recovered corneal clarity. No undesirable accumulation of HCECs in ocular tissue, elevation of IOP, or systemic side-effects was observed. Histological examination of the 31 organ-tissue samples revealed no tumor genesis or inflammatory response. Moreover, PCR examination of those samples revealed no genomic DNA derived from the donor HCECs.

Conclusions: The findings of this present study indicate that cell-injection therapy using cultivated HCECs is a safe and effective procedure, and one that might be clinically applicable for the treatment of corneal endothelial dysfunction.

Keywords: 481 cornea: endothelium • 480 cornea: basic science • 687 regeneration  
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