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  • hCECs for Endothelial Failure: Five-Year Results

    By Lynda Seminara
    Selected By: Stephen D. McLeod, MD

    Journal Highlights

    Ophthalmology, April 2021

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    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.