Corneal Stroma Enhancement With Decellularized Stromal Laminas With or Without Stem Cell Recellularization for Advanced Keratoconus

Abstract

This phase 1 study seeks to preliminarily evaluate the safety and efficacy of decellularized human corneal stromal lamina transplantation with or without autologous adipose-derived adult stem cell recellularization within the corneal stroma of patients with advanced keratoconus. Phase 1 clinical trial. Femtosecond-assisted 120-μm thickness and 9-mm diameter laminas were obtained from the anterior stroma of human donor corneas and decellularized with a sodium dodecyl sulfate solution. Autologous adipose-derived adult stem cells were obtained by elective liposuction and cultured onto both sides of the lamina. Five patients received the decellularized lamina alone and 4 patients the recellularized lamina into a femtosecond-assisted 9.5-mm diameter lamellar pocket under topical anesthesia. The total duration of follow-up was 6months. No case showed clinical haze or scarring by month 3. Six months after surgery, patients showed a general improvement of all visual parameters, with a mean unaided visual acuity from 0.109 to 0.232 (P= .05) and corrected distance visual acuity from 0.22 to 0.356 (P= .068). Refractive sphere improved in all patients (from-4.55 diopters [D] to-2.69 D; P= .017), but refractive cylinder remained stable (from-2.83 to-2.61; P= .34). An improvement tendency of all anterior keratometric values was observed. A mean improvement of 120μm in all thickness parameters was confirmed (P= .008), as well as an improvement in the spherical aberration (P= .018), coma (P= .23) and total higher order aberrations (P= .31). No significant differences among groups were detected. Decellularized human corneal stromal laminas transplantation seems safe and moderately effective for advanced keratoconus. Potential benefits of its recellularization with autologous adipose-derived adult stem cells remains unclear.