June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Xenotransplantation of human embryonic stem cell-derived RPE cells, MA09-hPRE, to the subretinal space of minipigs and various methods available for detection of adverse changes in eye
Author Affiliations & Notes
  • Joo Yong Lee
    Ophthalmology, Asan Medical Center, Seoul, Korea (the Republic of)
  • You Na Kim
    Ophthalmology, Asan Medical Center, Seoul, Korea (the Republic of)
  • Sung-Min Cho
    Asan Institute for Life Sciences and Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of)
  • Junyeop LEE
    Department of Ophthalmology, Yeungnam University, College of Medicine, Daegu, Korea (the Republic of)
  • Woo-Chan Son
    Asan Institute for Life Sciences and Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of)
  • Footnotes
    Commercial Relationships   Joo Yong Lee, None; You Na Kim, None; Sung-Min Cho, None; Junyeop LEE, None; Woo-Chan Son, None
  • Footnotes
    Support  Sponsored by CHA biotech Co, Ltd
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 4560. doi:
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      Joo Yong Lee, You Na Kim, Sung-Min Cho, Junyeop LEE, Woo-Chan Son; Xenotransplantation of human embryonic stem cell-derived RPE cells, MA09-hPRE, to the subretinal space of minipigs and various methods available for detection of adverse changes in eye. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4560.

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

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Abstract

Purpose : The purpose of this study was to determine the safety and tolerability of the subretinal injection of hESC-derived RPE cells in the laboratory minipig.

Methods : A volume of 150 µl of RPE reconstituted in BSS Plus was injected into the subretinal space of 16-month old laboratory minipigs (n=10) via a 23-G subretinal cannula, delivering the dose of 60 x 104 RPE cells and 120 x 104 RPE cells. Postoperative examinations were performed on postoperative day 1, week 1 and then weekly until the last follow-up using fundus photography and spectral-domain optical coherence tomography. Histologic and immunohistochemistry examination using CD3, CD 45 antibody was performed after enucleation.

Results : There was no serious systemic and ocular adverse event during the follow up (9 days – 12 weeks) Fundus photography revealed increased subretinal pigmentation after 4-6 weeks after subretinal injection. Spectral-domain OCT showed no significant morphologic changes during the follow-up. On immunohistochemistry examination, CD3 (+) and CD 45 (+) inflammatory cells were identified in the subretinal space.

Conclusions : Subretinal injection of high dose hESC-derived RPE cells was well tolerated in the preclinical study using minipig. These data suggest that high-dose hESC-derived RPE cells could be used for the treatment of degenerative macular diseases in the human trials.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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