Abstract
Purpose :
To evaluate efficiency and safety of transplantation of autologous and allogeneic limbal stem cells (LSC) cultured on human amniotic membrane with no feeders and to compare cultured LSC with limbal tissue transplantation.
Methods :
Design: Prospective phase II interventional clinical trial (NCT01619189; average follow-up time, 72 months) and retrospective control group (limbal tissue transplantation; average follow-up time, 132 months). Interventions: Autologous (autoLSC, n=7) and allogeneic (alloLSC, n=7) cultured LSC transplantation. Autologous (autoLT, n=8) and allogeneic (alloLT, n=8) limbal tissue transplantation. Main Outcome Measure: Survival of the grafted epithelium (Kaplan-Meier method) defined by absence of recurrence of the clinical signs of limbal deficiency in the central cornea.
Results :
The 5-year survival estimate was 71% for autoLSC, 0% for alloLSC, 75% for autoLT and 33% for alloLT (p=0.02); significantly better for autografts than allografts (p=0.004) with no significant differences between tissue grafts and cultured LSC grafts (p=0.39). From baseline to last visit, visual acuity improved by 9.2 lines for autoLSC and 3.3 lines for autoLT, whereas it decreased by 0.7 line for alloLSC and 1.9 lines for alloLT. Adverse events were recorded in 1 out of 7 autoLSC patients, 7 out of 7 alloLSC patients, 6 out of 8 autoLT patients and 8 out of 8 alloLT patients. Corneal epithelial defect requiring topical treatment was the only adverse event recorded after autoLSC, whereas severe sight-threatening adverse events were recorded in the remaining 3 groups. Compared with failed grafts, successful grafts featured greater decrease in fluorescein staining from baseline, higher superficial vascularization-free corneal area, lower variability of the corneal epithelial thickness, and higher corneal epithelial basal cell density, 3 years after transplantation.
Conclusions :
Transplantation of autologous cultured LSC was associated with high long-term survival, dramatic improvement in visual acuity and very low frequency of adverse events. Transplantation of autologous limbal tissue resulted in similar efficiency but lower safety. Transplantation of cadaver donor allogeneic cultured LSC or limbal tissue resulted in low long-term success rate and high prevalence of serious adverse events.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.