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.

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.