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
Published 2026 - 44th Congress of the ESCRS
Reference: FP18.13 | Type: Free paper | DOI: 10.82333/7w7x-4d34
Authors: A/Prof. Jorge L. Alió* 1 , A/Prof. Jorge L. Alió del Barrio 1 , Dr Hao Zhang 1 , A/Prof. Rafael Barraquer 2 , Dr Alejandra E. Rodriguez 3 , A/Prof. Francisco Arnalich-Montiel 4 , Dr David Mingo-Botín 5 , A/Prof. María Eugenia Fernández Santos 6
1Vissum Grupo Miranza,Alicante,Spain;Division of Ophthalmology,Universidad Miguel Hernández,Alicante,Spain, 2Centro de Oftalmología Barraquer,Barcelona,Spain;Institut Universitari Barraquer, Universitat Autònoma de Barcelona,Barcelona,Spain;Universitat Internacional de Catalunya,Barcelona,Spain, 3Vissum Grupo Miranza,Alicante,Spain, 4Department of Ophthalmology, Hospital Universitario Ramón y Cajal,Madrid,Spain;Departamento de Medicina, Facultad de Medicina, Universidad Ceu San Pablo, Campus de Montepríncipe,Boadilla,Spain, 5Department of Ophthalmology, Hospital Universitario Ramón y Cajal,Madrid,Spain, 6ATMPs Production Unit of the Health Research Institute of the Gregorio Marañón Hospital,Madrid,Spain
Purpose
To evaluate the 1-year safety and efficacy of decellularised human corneal stromal lamina implantation, with or without autologous adipose-derived adult stem cells (ADASCs), for advanced keratoconus in a European cohort.
Setting
Prospective, randomized, double-masked, phase I/IIa clinical trial
Methods
This trial enrolled 10 patients (10 eyes) randomised into two groups. Group 1 (G-1; n=5) received a 120-µm decellularised stromal lamina. Group 2 (G-2; n=5) received the same lamina recellularised with autologous ADASCs (1.0×106 cells) plus 2.0×106 ADASCs injected into the stromal pocket. All procedures used femtosecond laser–assisted 9.5-mm intrastromal dissection.
Results
No major intraoperative complications occurred; one G-2 micro-tear resolved without sequelae. No clinically significant inflammation, rejection, or graft failure was observed. Transparency was restored in all eyes by 3–6 months, with faster recovery in G-2. At 12 months, UDVA improved by 2.14±0.71 lines (G-1) versus 1.30±0.84 lines (G-2) (P=0.18). CDVA improved by 2.48±0.66 lines (G-1) versus 1.43±0.53 lines (G-2) (P=0.0057). CCT increased by ~120 µm in both arms (+118.4 vs +121.2 µm), with stable keratometric indices. IVCM showed progressive lamina repopulation in both groups, earlier and with higher stromal cell density in G-2.
Conclusions
Decellularised stromal lamina implantation—alone or with autologous ADASCs—was safe and produced sustained stromal thickening with clinically meaningful visual improvement at 12 months. Visual outcomes tended to be better with lamina implantation alone in this cohort.