June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Phase 1 Multicenter Study of Magnetic Cell Therapy for Corneal Edema
Author Affiliations & Notes
  • Noelia Kunzevitzky
    Emmecell, Menlo Park, California, United States
  • Christina Fleming
    Emmecell, Menlo Park, California, United States
  • Jennifer K Thoele
    Emmecell, Menlo Park, California, United States
  • Roger Goldberg
    Emmecell, Menlo Park, California, United States
    Bay Area Retina Associates, Walnut Creek, California, United States
  • Jeffrey L Goldberg
    Emmecell, Menlo Park, California, United States
    Ophthalmology, Stanford University, Palo Alto, California, United States
  • Footnotes
    Commercial Relationships   Noelia Kunzevitzky Emmecell, Code E (Employment), Emmecell, Code P (Patent); Christina Fleming Emmecell, Code E (Employment); Jennifer Thoele Emmecell, Code E (Employment); Roger Goldberg Emmecell, Code O (Owner), Emmecell, Code P (Patent), Emmecell, Code S (non-remunerative); Jeffrey Goldberg Emmecell, Code O (Owner), Emmecell, Code P (Patent), Emmecell, Code S (non-remunerative)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 2758 – A0247. doi:
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    • Get Citation

      Noelia Kunzevitzky, Christina Fleming, Jennifer K Thoele, Roger Goldberg, Jeffrey L Goldberg; Phase 1 Multicenter Study of Magnetic Cell Therapy for Corneal Edema. Invest. Ophthalmol. Vis. Sci. 2022;63(7):2758 – A0247.

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

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Abstract

Purpose :
To assess the safety and tolerability of magnetic cell therapy as treatment for subjects with corneal edema secondary to Fuchs’ endothelial corneal dystrophy (FECD) or pseudophakic bullous keratopathy (PBK).

Methods : Human corneal endothelial cells were isolated from donor corneas,
expanded in vitro and labeled with biocompatible magnetic nanoparticles to formulate
EO2002, magnetic human corneal endothelial cells.
The safety and tolerability of a single intracameral injection of magnetic human corneal
endothelial cells (EO2002) with and without endothelial brushing (EB) or Descemet
stripping (DS) will be assessed in a phase 1, open-label, dose-escalating multicenter
study. In total, 18 subjects with corneal edema will be enrolled in the study and will
receive a single dose of EO2002 followed by the application of an external magnetic
eye patch. Half of the subjects will only receive an injection of EO2002 and the other
half will undergo EB or DS followed by EO2002 injection. Three doses will be studied
over a 6-month follow-up period. The primary endpoints are the absence of
inflammation and a stable intraocular pressure. The secondary endpoints will assess
changes in corneal thickness and in best corrected visual acuity (BCVA).

Results :
Study enrollment for pseudophakic subjects that are surgical candidates for DSEK with BCVA <20/40 is ongoing. To date, 9 subjects were enrolled and treated with EO2002 with and without DS. No product-related SAEs have occurred.

Conclusions :
EO2020 injection in subjects with symptomatic corneal edema is well-tolerated, with no significant adverse events or changes in intraocular pressure. Forthcoming data from the remainder of the study should provide valuable information on the safety of all doses as well as essential data on secondary endpoints in this patient population.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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