Jorge L Alió Del Barrio1, Mona El Zarif2, Albert Azaar3, Nehman Makdissy4, Charbel Khalil3, Walid Harb3, Ibrahim El Achkar5, Ziad Abdul Jawad2, María P de Miguel6, Jorge L Alió7. 1. Cornea, Cataract and Refractive Surgery Unit, Vissum Corporación, Alicante, Spain; Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain. 2. Optica General, Saida, Lebanon. 3. Reviva Regenerative Medicine Center, Middle East Hospital, Beirut, Lebanon. 4. Reviva Regenerative Medicine Center, Middle East Hospital, Beirut, Lebanon; Lebanese University, Beirut, Lebanon. 5. Saint-Joseph University, Beirut, Lebanon. 6. Cell Engineering Laboratory, IdiPAZ, La Paz Hospital Research Institute, Madrid, Spain. 7. Cornea, Cataract and Refractive Surgery Unit, Vissum Corporación, Alicante, Spain; Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain. Electronic address: jlalio@vissum.com.
Abstract
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.
RCT Entities:
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 humandonor 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.
Authors: Marcus Ang; Damien Gatinel; Dan Z Reinstein; Erik Mertens; Jorge L Alió Del Barrio; Jorge L Alió Journal: Eye (Lond) Date: 2020-07-24 Impact factor: 3.775
Authors: S Sharareh Mahdavi; Mohammad J Abdekhodaie; Shohreh Mashayekhan; Alireza Baradaran-Rafii; Ali R Djalilian Journal: Tissue Eng Regen Med Date: 2020-07-21 Impact factor: 4.169
Authors: Francisco Arnalich-Montiel; Adrian Moratilla; Sherezade Fuentes-Julián; Veronica Aparicio; Marta Cadenas Martin; Gary Peh; Jodhbir S Mehta; Khadijah Adnan; Laura Porrua; Ane Pérez-Sarriegui; Maria P De Miguel Journal: PLoS One Date: 2019-11-21 Impact factor: 3.240