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mariam dhundass, Nacim Bouheraoua, Otman Sandali, Elena Basli, Laurent Laroche, Vincent Borderie; Cultured limbal stem cells transplantation for severe limbal deficiency. Prospective phase II clinical trial.. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5185.
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To evaluate cultured limbal stem cells transplantation for treating severe limbal deficiency
Thirteen patients with total limbal deficiency were included in a phase II prospective clinical trial (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. 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).
The mean follow-up time was 33 months. The post-operative visual acuity at M12 (1.5 LogMAR + 7 lines) and M18 (1.6 LogMAR + 7 lines) was better than the preoperative visual acuity (2.3 LogMAR + 4 lines) (p<0,005). The mean improvement in visual acuity at M12 was 8.0 lines for allografts and 8.0 lines for autografts (p=0.88). The ocular surface symptom index was better at 12 months compared with preoperative values (2.7+1.2 versus 4.1+1.5) (p=0.03) with no significant differences between auto and allografts (p=0.88). The mean fluorescein staining area decreased from 4131 µ2 before transplantation to 2059 µ2 at M12 (p=0.04). This figure at M12 was 496 µ2 for autografts and 3176 µ2 for allografts (p=0.04). The mean Schirmer test result at 3 minutes was 15+10 mm preoperatively and 19+12 mm at M12 (p=0.23).
Cultured limbal stem cell transplantation was associated with significant visual acuity improvement, decreased fluorescein staining and decreased symptoms.
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