hCECs for Endothelial Failure: Five-Year Results
Ophthalmology, April 2021
Building on their previous investigations of cultured human corneal endothelial cells (hCECs) to manage endothelial failure, Numa et al. evaluated long-term postoperative results of the first clinical trial in humans. They found that normal corneal endothelial function was restored in 10 of 11 eyes by the five-year mark, and no serious adverse reactions occurred.
This prospective observational study included 11 patients (11 eyes) with a pseudophakic endothelial failure condition (e.g., Fuchs endothelial corneal dystrophy or corneal edema). All eyes had been implanted with a posterior chamber IOL.
The researchers’ novel procedure involves simultaneous injection of cultured hCEC cells supplemented with a Rho-associated protein kinase inhibitor to promote CEC engraftment. After injection, follow-up occurred at weeks 1, 4, 12, and 24 during the first year and annually thereafter. The primary outcome was the change in central corneal endothelial cell density (ECD) following therapy. Other outcome measures were corneal thickness, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) during follow-up.
Within five years of the procedure, normal corneal endothelial function was restored in 10 of the 11 eyes. The mean (standard deviation) value for central corneal ECD was 1,257 (467) cells/mm2. BCVA improved significantly in 10 eyes; mean log-MAR values at baseline and five years were 0.876 and 0.046, respectively. No major adverse effects occurred.
The authors describe their approach as “a paradigm shift in corneal regenerative medicine, with potential clinical application to patients worldwide.” They added that therapeutic outcomes could be enhanced by further improving the biological quality of cultured hCECs and learning more about efficacy across a wide range of conditions.
The original article can be found here.