Five-Year Follow-up of First 11 Patients Undergoing Injection of Cultured Corneal Endothelial Cells for Corneal Endothelial Failure

Ophthalmology. 2021 Apr;128(4):504-514. doi: 10.1016/j.ophtha.2020.09.002. Epub 2020 Sep 6.

Abstract

Purpose: To report the safety and efficacy of a novel cell injection therapy using cultured human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of the long-term 5-year postoperative clinical data from a first-in-humans clinical trial group.

Design: Prospective observational study.

Participants: This study involved 11 eyes of 11 patients with pseudophakic endothelial failure conditions who underwent hCEC injection therapy between December 2013 and December 2014.

Methods: All patients underwent follow-up examinations at 1 week, 4 weeks, 12 weeks, and 24 weeks and 1 year, 2 years, 3 years, 4 years, and 5 years after surgery. Specific corneal endothelial cell parameters (i.e., corneal endothelial cell density [ECD], coefficient of variation of area, and percentage of hexagonal cells) and central corneal thickness, best-corrected visual acuity (BCVA) on a Landolt C eye chart, and intraocular pressure (IOP) were recorded.

Main outcome measures: The primary outcome was the change in central ECD after cell injection therapy, and the secondary outcome was corneal thickness, BCVA, and IOP during the 5-year-postoperative follow-up period.

Results: At 5 years after surgery, normal corneal endothelial function was restored in 10 of the 11 eyes, the mean ± standard deviation central corneal ECD was 1257 ± 467 cells/mm2 (range, 601-2067 cells/mm2), BCVA improved significantly in 10 treated eyes, the mean visual acuity changed from 0.876 logarithm of the minimum angle of resolution before surgery to 0.046 logarithm of the minimum angle of resolution after surgery, and no major adverse reactions directly related to the hCEC injection therapy were observed.

Conclusions: The findings in this study confirmed the safety and efficacy of cultured hCEC injection therapy for up to 5 years after surgery.

Keywords: Cell injection; Corneal endothelial failure; Cultured corneal endothelial cells; Regenerative medicine; Rho-associated protein kinase inhibitor.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Amides / therapeutic use*
  • Anterior Chamber
  • Cell Count
  • Cells, Cultured
  • Combined Modality Therapy
  • Corneal Edema / diagnosis
  • Corneal Edema / physiopathology
  • Corneal Edema / therapy*
  • Endothelium, Corneal / cytology
  • Endothelium, Corneal / transplantation*
  • Female
  • Follow-Up Studies
  • Fuchs' Endothelial Dystrophy / diagnosis
  • Fuchs' Endothelial Dystrophy / physiopathology
  • Fuchs' Endothelial Dystrophy / therapy*
  • Graft Rejection / prevention & control
  • Humans
  • Injections, Intraocular
  • Intraocular Pressure / physiology
  • Male
  • Middle Aged
  • Prone Position
  • Prospective Studies
  • Protein Kinase Inhibitors / therapeutic use*
  • Pyridines / therapeutic use*
  • Regenerative Medicine
  • Slit Lamp Microscopy
  • Visual Acuity / physiology
  • rho-Associated Kinases / antagonists & inhibitors*

Substances

  • Amides
  • Protein Kinase Inhibitors
  • Pyridines
  • Y 27632
  • rho-Associated Kinases