MAR 13, 2019
Cornea/External Disease, Refractive Mgmt/Intervention
This study evaluates the 1-year safety and efficacy of an adipose-derived adult stem cell (ADASc) implant, applied with or without sheets of decellularized donor human corneal stroma, in patients with advanced keratoconus.
The authors performed a prospective interventional non-randomized study of 14 consecutive patients with advanced keratoconus. Each underwent implantation with either 1) autologous ADASc, 2) decellularized 120-μm thick corneal stroma lamina from a donor or 3) donor lamina recellularized with 1x106 autologous ADASc with an additional 1x106 cells at the time of surgery. Autologous ADASc were obtained by elective liposuction. Implantation was performed into the corneal stroma through a femtosecond-assisted 9.5-mm diameter lamellar dissection under topical anesthesia.
Twelve months after implantation, the average corrected distance visual acuity improved by 0.231, 0.264 and 0.094 Snellen lines in groups 1, 2 and 3, respectively. In group 1, refractive parameters showed an overall stability, while sphere improved by 2.35D and 0.625D in groups 2 and 3, respectively. Anterior keratometry remained stable in group 1 and improved in groups 2 and 3 by an average of 2 D. No adverse events or complications were noted.
The study was limited by a small sample size with only 1 year of follow-up data.
These findings introduce a new potential treatment for patients who have a high risk of perforation with deep anterior lamellar keratoplasty (DALK) or who may not fare well with a full-thickness transplant. The procedure appears to carry a low level of risk, though the study should be repeated in a larger population with longer follow-up times. It is noted, however, that vision did not improve enough to match the results of DALK or penetrating keratoplasty.