Cultured limbal stem cell versus limbal tissue transplantation for treating severe limbal deficiency

Abstract

Purpose: To compare cultured limbal stem cell transplantation with limbal tissue transplantation for treating severe limbal deficiency.

Methods: Thirteen patients with total limbal deficiency were included in a phase II prospective clinical trial (TC181, ClinicalTrials.gov Identifier: NCT01619189). Treatment consisted of transplantation of limbal stem cells cultured from superficial limbal explants, either autologous (n=6) or allogeneic (n=7), on human amniotic membrane. This study group was compared with a retrospective control group including 20 limbal tissue autografts (n=12) or allografts (n=8) performed for total limbal deficiency. Before transplantation all eyes featured irregular corneal epithelium with abnormal fluorescein permeability on the whole corneal surface, superficial corneal vascularization, and presence of goblet cells in the corneal epithelium in vivo (confocal microscopy or corneal impression cytology) and ex vivo (histology).

Results: The mean follow-up time was 41 months. The post-operative visual acuity at M6 (1.6 LogMAR + 7 lines), M12 (1.5 LogMAR + 8 lines), and M24 (1.6 LogMAR + 8 lines) was better than the preoperative visual acuity (2.0 LogMAR + 5 lines) (p<0,005). The mean improvement in visual acuity was 8.0 lines in the study group and 3.0 lines in the control group (p=0.02). This figure was 5.2 lines for autografts and 4.8 lines for allografts (p=0.85).

Conclusions: Cultured limbal stem cell transplantation was associated with better visual recovery compared with limbal tissue transplantation. Visual recovery was not significantly better in autologous cases compared with allogeneic ones.

Keywords: 479 cornea: clinical science • 721 stem cells • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials