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.
Zhang H., Alió Del Barrio JL., Rodriguez AE., Barraquer RI., Arnalich-Montiel F., Mingo-Botín D.
Clinical Trial with a reported sample of 5, published in Clin Exp Ophthalmol (2026) — summary generated from the PubMed abstract.
Several human studies show positive signals, while research methods and sample sizes continue to develop.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Clinical Trial
- Journal
- Clin Exp Ophthalmol (2026)
- Country
- Australia
- Reported sample size
- 5
- Source database
- PubMed
- PMID
- 42414854
- DOI
- 10.1111/ceo.70141
Abstract (original English)
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 × 10 6 autologous ADASCs plus 2.0 × 10 6 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 Dec
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Several human studies show positive signals, while research methods and sample sizes continue to develop.
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