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Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures.

Ramírez BE, Sánchez A, Herreras JM, Fernández I, García-Sancho J, Nieto-Miguel T, Calonge M - Biomed Res Int (2015)

Bottom Line: All clinical parameters improved substantially.By IVCM, 80% of cases improved in epithelial status.These results confirm that CLET is a valid therapy for ocular surface failure.

View Article: PubMed Central - PubMed

Affiliation: Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.

ABSTRACT

Objective: To evaluate outcomes of cultivated limbal epithelial transplantation (CLET) for management of ocular surface failure due to limbal stem cell deficiency (LSCD).

Design: Prospective, noncomparative, interventional case series and extensive comparison with recent similar studies.

Participants: Twenty eyes with LSCD underwent CLET (11 autologous; 9 allogeneic) and were followed up for 3 years. Etiologies were divided into 3 prognostic categories: Group 1, chemical injuries (7 eyes); Group 2, immune-based inflammation (4 eyes); and Group 3, noninflammatory diseases (9 eyes). Intervention. Autologous and allogeneic limbal epithelial cells were cultivated on amniotic membranes and transplanted. Evaluations were based on clinical parameters, survival analysis, and in vivo confocal microscopy (IVCM). European Union Tissues/Cells Directive and good manufacturing procedures were followed.

Main outcome measures: Improved clinical parameters, absence of epithelial defects, and improved central corneal epithelial phenotype.

Results: Success rate was 80% at 1-2 years and 75% at 3 years. Autografts and allografts had similar survival. Success rate was significantly lower in prognostic Group 1 (42.9%) than in Groups 2-3 (100% each). All clinical parameters improved substantially. By IVCM, 80% of cases improved in epithelial status.

Conclusions: CLET improved corneal epithelium quality, with subsequent improvement in symptoms, quality of life, and vision. These results confirm that CLET is a valid therapy for ocular surface failure.

No MeSH data available.


Related in: MedlinePlus

Case 8 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 36-year-old man had limbal stem cell deficiency due to a unilateral chemical burn, with vascular pannus invading the visual axis (a). (a1) In vivo confocal microscopy (IVCM) shows a typical conjunctival-like epithelial phenotype in his central cornea (star), with goblet cells (arrow) and fibrosis (black arrowhead). This case was graded preoperatively in terms of visual prognosis as Grade 1, meaning that only cultivated epithelial transplantation (CLET) would be required for visual rehabilitation. After 12 months, this case was considered successful as all clinical signs improved (b) and symptoms decreased and IVCM showed an epithelial corneal phenotype (b1).
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fig4: Case 8 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 36-year-old man had limbal stem cell deficiency due to a unilateral chemical burn, with vascular pannus invading the visual axis (a). (a1) In vivo confocal microscopy (IVCM) shows a typical conjunctival-like epithelial phenotype in his central cornea (star), with goblet cells (arrow) and fibrosis (black arrowhead). This case was graded preoperatively in terms of visual prognosis as Grade 1, meaning that only cultivated epithelial transplantation (CLET) would be required for visual rehabilitation. After 12 months, this case was considered successful as all clinical signs improved (b) and symptoms decreased and IVCM showed an epithelial corneal phenotype (b1).

Mentions: Evaluation of the central corneal epithelial cell phenotypes by laser IVCM was the most objective primary endpoint [24, 33]. Before CLET, 13 eyes (65%; Cases 3, 4, 8, 9–17, and 20) had a conjunctival epithelial phenotype in the central cornea (Figures 3–5). One year after CLET, 6 of the 13 cases (Cases 3, 8–10, 13, and 20) improved to the corneal-like epithelium phenotype (Figure 4), and 5 eyes (Cases 4, 11, 12, 14, and 15) evolved to a mixed phenotype (Figure 5). The partially successful case (Case 17) and one of the 3 failed cases (Case 17) maintained the conjunctival phenotype. The remaining 7 eyes (Cases 1, 2, 5–7, 18, and 19) were classified in the initial examination as having the mixed epithelium phenotype. One year after CLET, 5 of these eyes (71.43%) changed to the corneal phenotype (Cases 2, 5–7, and 19). The 2 remaining cases (Cases 1 and 18) worsened to the conjunctival phenotype and were consequently considered failures. The type of transplant, autograft or allograft, had no influence in these results (Fisher's exact test, initial visit p = 0.6424, final visit p = 0.3359).


Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures.

Ramírez BE, Sánchez A, Herreras JM, Fernández I, García-Sancho J, Nieto-Miguel T, Calonge M - Biomed Res Int (2015)

Case 8 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 36-year-old man had limbal stem cell deficiency due to a unilateral chemical burn, with vascular pannus invading the visual axis (a). (a1) In vivo confocal microscopy (IVCM) shows a typical conjunctival-like epithelial phenotype in his central cornea (star), with goblet cells (arrow) and fibrosis (black arrowhead). This case was graded preoperatively in terms of visual prognosis as Grade 1, meaning that only cultivated epithelial transplantation (CLET) would be required for visual rehabilitation. After 12 months, this case was considered successful as all clinical signs improved (b) and symptoms decreased and IVCM showed an epithelial corneal phenotype (b1).
© Copyright Policy - open-access
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4588357&req=5

fig4: Case 8 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 36-year-old man had limbal stem cell deficiency due to a unilateral chemical burn, with vascular pannus invading the visual axis (a). (a1) In vivo confocal microscopy (IVCM) shows a typical conjunctival-like epithelial phenotype in his central cornea (star), with goblet cells (arrow) and fibrosis (black arrowhead). This case was graded preoperatively in terms of visual prognosis as Grade 1, meaning that only cultivated epithelial transplantation (CLET) would be required for visual rehabilitation. After 12 months, this case was considered successful as all clinical signs improved (b) and symptoms decreased and IVCM showed an epithelial corneal phenotype (b1).
Mentions: Evaluation of the central corneal epithelial cell phenotypes by laser IVCM was the most objective primary endpoint [24, 33]. Before CLET, 13 eyes (65%; Cases 3, 4, 8, 9–17, and 20) had a conjunctival epithelial phenotype in the central cornea (Figures 3–5). One year after CLET, 6 of the 13 cases (Cases 3, 8–10, 13, and 20) improved to the corneal-like epithelium phenotype (Figure 4), and 5 eyes (Cases 4, 11, 12, 14, and 15) evolved to a mixed phenotype (Figure 5). The partially successful case (Case 17) and one of the 3 failed cases (Case 17) maintained the conjunctival phenotype. The remaining 7 eyes (Cases 1, 2, 5–7, 18, and 19) were classified in the initial examination as having the mixed epithelium phenotype. One year after CLET, 5 of these eyes (71.43%) changed to the corneal phenotype (Cases 2, 5–7, and 19). The 2 remaining cases (Cases 1 and 18) worsened to the conjunctival phenotype and were consequently considered failures. The type of transplant, autograft or allograft, had no influence in these results (Fisher's exact test, initial visit p = 0.6424, final visit p = 0.3359).

Bottom Line: All clinical parameters improved substantially.By IVCM, 80% of cases improved in epithelial status.These results confirm that CLET is a valid therapy for ocular surface failure.

View Article: PubMed Central - PubMed

Affiliation: Institute of Applied Ophthalmobiology (IOBA), University of Valladolid, Campus Universitario Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.

ABSTRACT

Objective: To evaluate outcomes of cultivated limbal epithelial transplantation (CLET) for management of ocular surface failure due to limbal stem cell deficiency (LSCD).

Design: Prospective, noncomparative, interventional case series and extensive comparison with recent similar studies.

Participants: Twenty eyes with LSCD underwent CLET (11 autologous; 9 allogeneic) and were followed up for 3 years. Etiologies were divided into 3 prognostic categories: Group 1, chemical injuries (7 eyes); Group 2, immune-based inflammation (4 eyes); and Group 3, noninflammatory diseases (9 eyes). Intervention. Autologous and allogeneic limbal epithelial cells were cultivated on amniotic membranes and transplanted. Evaluations were based on clinical parameters, survival analysis, and in vivo confocal microscopy (IVCM). European Union Tissues/Cells Directive and good manufacturing procedures were followed.

Main outcome measures: Improved clinical parameters, absence of epithelial defects, and improved central corneal epithelial phenotype.

Results: Success rate was 80% at 1-2 years and 75% at 3 years. Autografts and allografts had similar survival. Success rate was significantly lower in prognostic Group 1 (42.9%) than in Groups 2-3 (100% each). All clinical parameters improved substantially. By IVCM, 80% of cases improved in epithelial status.

Conclusions: CLET improved corneal epithelium quality, with subsequent improvement in symptoms, quality of life, and vision. These results confirm that CLET is a valid therapy for ocular surface failure.

No MeSH data available.


Related in: MedlinePlus