American journal of ophthalmology · 2017
Corneal Stroma Enhancement With Decellularized Stromal Laminas With or Without Stem Cell Recellularization for Advanced Keratoconus.
Клиническое исследование I фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Alió Del Barrio Jorge L, El Zarif Mona, Azaar Albert, Makdissy Nehman, Khalil Charbel, Harb Walid, El Achkar Ibrahim, Jawad Ziad Abdul, de Miguel María P, Alió Jorge L
Аннотация
PURPOSE: 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.
DESIGN: Phase 1 clinical trial.
METHODS: 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 6 months.
RESULTS: 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 120 μm 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.
CONCLUSIONS: 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.
DESIGN: Phase 1 clinical trial.
METHODS: 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 6 months.
RESULTS: 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 120 μm 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.
CONCLUSIONS: 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.
Предметные рубрики MeSH
AdultCells, CulturedCorneal PachymetryCorneal StromaCorneal TopographyCorneal TransplantationFemaleFollow-Up StudiesHumansKeratoconusMaleMiddle AgedProspective StudiesRefraction, OcularSeverity of Illness IndexStem Cell TransplantationStem CellsTime FactorsTomography, Optical CoherenceTransplantation, AutologousTreatment OutcomeVisual AcuityYoung Adult