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Decellularised Corneal Stromal Lamina With or Without Autologous Adipose-Derived Adult Stem Cells for Advanced Keratoconus: 1-Year Results of a Phase I/IIa Clinical Trial.

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Title: Decellularised Corneal Stromal Lamina With or Without Autologous Adipose-Derived Adult Stem Cells for Advanced Keratoconus: 1-Year Results of a Phase I/IIa Clinical Trial.
Authors: Zhang H; Cornea, Cataract and Refractive Surgery Unit, Vissum (Miranza Group), Alicante, Spain.; Division of Ophthalmology, School of Medicine, Universidad Miguel Hernández, Alicante, Spain., Alió Del Barrio JL; Cornea, Cataract and Refractive Surgery Unit, Vissum (Miranza Group), Alicante, Spain.; Division of Ophthalmology, School of Medicine, Universidad Miguel Hernández, Alicante, Spain., El Zarif M; Genomic Surveillance and Biotherapy (GSBT), Faculty of Sciences, Lebanese University, Ras Maska, Lebanon.; Doctoral School of Sciences and Technology, and Faculty of Public Health, Lebanese University, Hadath, Lebanon.; Ophthalmology Clinic, Department of Medicine and Aging Sciences, University 'G. d'Annunzio' of Chieti-Pescara, Chieti, Italy.; Department of Medicine and Aging Science, Center for Advanced Studies and Technology (CAST), University G. d'Annunzio of Chieti-Pescara, Chieti, Italy.; Optica General, Saida, Lebanon.; Division of Ophthalmology, Universidad Miguel Hernández, Campus of San Juan Alicante, Elche, Spain., Rodriguez AE; Cornea, Cataract and Refractive Surgery Unit, Vissum (Miranza Group), Alicante, Spain., Barraquer RI; Centro de Oftalmología Barraquer, Barcelona, Spain.; Institut Universitari Barraquer, Universitat Autònoma de Barcelona, Barcelona, Spain.; Universitat Internacional de Catalunya, Barcelona, Spain., Arnalich-Montiel F; Department of Ophthalmology, Hospital Universitario Ramón y Cajal, Madrid, Spain.; Departamento de Medicina, Facultad de Medicina, Universidad Ceu San Pablo, Campus de Montepríncipe, Boadilla, Spain., Mingo-Botín D; Department of Ophthalmology, Hospital Universitario Ramón y Cajal, Madrid, Spain., Fernández-Santos ME; ATMPs Production Unit of the Institute for Health Research at the Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Spain., De Miguel MP; Cell Engineering Laboratory, La Paz University Hospital Health Research Institute (IdiPAZ), Madrid, Spain., Alió JL; Cornea, Cataract and Refractive Surgery Unit, Vissum (Miranza Group), Alicante, Spain.; Division of Ophthalmology, School of Medicine, Universidad Miguel Hernández, Alicante, Spain.
Source: Clinical & experimental ophthalmology [Clin Exp Ophthalmol] 2026 Sep-Oct; Vol. 54 (7), pp. 883-894. Date of Electronic Publication: 2026 Jul 07.
Publication Type: Journal Article; Clinical Trial, Phase I; Randomized Controlled Trial; Clinical Trial, Phase II
Language: English
Journal Info: Publisher: Wiley-Blackwell Pub. Asia Country of Publication: Australia NLM ID: 100896531 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1442-9071 (Electronic) Linking ISSN: 14426404 NLM ISO Abbreviation: Clin Exp Ophthalmol Subsets: MEDLINE
Imprint Name(s): Publication: Carlton, Vic. : Wiley-Blackwell Pub. Asia
Original Publication: Carlton, Vic. : Blackwell Science Asia, c2000-
MeSH Terms: Keratoconus*/surgery , Keratoconus*/physiopathology , Keratoconus*/diagnosis , Corneal Stroma*/transplantation , Adipose Tissue*/cytology , Adult Stem Cells*/transplantation , Adult Stem Cells*/cytology, Visual Acuity/physiology ; Refraction, Ocular/physiology ; Humans ; Adult ; Female ; Prospective Studies ; Male ; Transplantation, Autologous ; Corneal Topography ; Young Adult ; Follow-Up Studies ; Corneal Pachymetry ; Middle Aged ; Treatment Outcome ; Tomography, Optical Coherence
Abstract: Background: To report the 1-year clinical outcomes of decellularised human corneal stromal lamina implantation, with or without autologous adipose-derived adult stem cells (ADASCs), for advanced keratoconus in a European cohort.
Methods: In this prospective, randomised Phase I/IIa trial, 10 eyes of 10 patients were allocated to decellularised stromal lamina implantation alone (G-1; n = 5) or lamina recellularised with 1.0 × 106 autologous ADASCs plus 2.0 × 106 additional ADASCs injected into the stromal pocket (G-2; n = 5). All procedures used femtosecond laser-assisted 9.5-mm intrastromal dissection.
Results: No major intraoperative complications occurred except one G-2 micro-tear that resolved. No clinically relevant inflammation, rejection, or graft failure was observed; transparency was restored in all eyes by 3-6 months. At 12 months, central corneal thickness increased by 118.4 μm in G-1 and 121.2 μm in G-2. Decimal UDVA improved by 2.14 ± 0.71 lines in G-1 and 1.30 ± 0.84 lines in G-2; decimal CDVA improved by 2.48 ± 0.66 and 1.43 ± 0.53 lines, respectively. Manifest sphere improved to -1.10 D in G-1 and -0.58 D in G-2, whereas manifest cylinder changed minimally in both groups. Keratometric indices remained largely unchanged. In vivo confocal microscopy demonstrated progressive cellular repopulation of the implanted lamina during follow-up in both groups.
Conclusions: Decellularised stromal lamina implantation, with or without autologous ADASCs, was safe and feasible, maintaining corneal transparency and producing sustained stromal thickening with clinically meaningful visual and refractive improvement at 12 months. Larger adequately powered studies with longer follow-up are required to assess clinical efficacy.
(© 2026 Royal Australian and New Zealand College of Ophthalmologists.)
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Grant Information: COlR: 240112110603 Fundación Navarro Tripodi; PI23/00207 Instituto de Salud Carlos III (ISCIII)
Contributed Indexing: Keywords: adipose‐derived mesenchymal stem cells; corneal stromal regeneration; decellularised corneal stromal lamina; keratoconus; visual acuity
Entry Date(s): Date Created: 20260707 Date Completed: 20261007 Latest Revision: 20261013
Update Code: 20261013
DOI: 10.1111/ceo.70141
PMID: 42414854
Database: MEDLINE
Description
ISSN:1442-9071
DOI:10.1111/ceo.70141