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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)
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.
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.
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.
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.
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