Cultured Cells Plus ROCK Inhibitor for Bullous Keratopathy
New England Journal of Medicine
Kinoshita et al. combined injections of corneal endothelial cells (CECs) with a Rho kinase (ROCK) inhibitor in patients with bullous keratopathy. They observed a large increase in cell density and no adverse immune response.
This uncontrolled single-group study included 11 patients (11 eyes) with bullous keratopathy who had no detectable CECs. Seven lots of cultured human CECs (passaged 2 or 3 times) were used; each lot was attained from an independent donor. A total of 1 × 106 passaged cells were supplemented with a ROCK inhibitor (final volume, 300 μL) and injected into the anterior chamber of the eye. Immediately after the procedure, patients were placed in the prone position for 3 hours. The primary outcome was restoration of corneal transparency, with a CEC density of >500 cells/mm2 at the central cornea, by 24 weeks after injection. Secondary 24-week outcomes included corneal thickness <630 μm and improvement in best-corrected visual acuity (BCVA) of ≥2 lines on the Landolt C eye chart.
Twenty-four weeks after injection, CEC density exceeded 500 cells/mm2 in all 11 eyes (range, 947-2,833); in 10 eyes, density surpassed 1,000 cells/mm2. Corneal thickness of <630 μm (range, 489-640) was attained in 10 eyes, and BCVA improved by at least 2 lines in 9 eyes. There were no occurrences of anterior uveitis, intraocular infection, or immunologic reaction. In the 2 years after injection, only 1 patient had an increase in intraocular pressure (to 27 mm Hg), which occurred at 8 months and was resolved with trabeculectomy.
The original article can be found here.