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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 17 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 52-year-old male suffered a chemical injury in his right eye 5 years earlier. He developed total limbal stem cell deficiency and showed at the initial visit an opaque and vascularized cornea (a) with a conjunctival-like phenotype at in vivo confocal microscopy (IVCM) in central cornea (star), with goblet cells (horizontal arrow), inflammatory cells (vertical arrow), and Langerhans cell (circle), (a1). He received an allogeneic cultivated limbal epithelial transplantation (CLET). (b) After 12 months and although his symptoms and ciliary hyperemia had improved, this case was considered a CLET failure as his epithelial phenotype in central cornea (b1) was still conjunctival-like (star), with inflammatory cells (vertical arrow), evaluated by IVCM.
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fig3: Case 17 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 52-year-old male suffered a chemical injury in his right eye 5 years earlier. He developed total limbal stem cell deficiency and showed at the initial visit an opaque and vascularized cornea (a) with a conjunctival-like phenotype at in vivo confocal microscopy (IVCM) in central cornea (star), with goblet cells (horizontal arrow), inflammatory cells (vertical arrow), and Langerhans cell (circle), (a1). He received an allogeneic cultivated limbal epithelial transplantation (CLET). (b) After 12 months and although his symptoms and ciliary hyperemia had improved, this case was considered a CLET failure as his epithelial phenotype in central cornea (b1) was still conjunctival-like (star), with inflammatory cells (vertical arrow), evaluated by IVCM.

Mentions: Even in the failed Cases 1, 17, and 18, there was subjective improvement as shown by lower OSDI scores and higher NEI-VFQ-25 scores (Table 1). Case 1 had another CLET (Case 16) in which the final outcome was graded as a partial success. This patient elected not to try to rehabilitate his chemically injured right eye any further as he remained mostly asymptomatic, and his left eye had full vision. Failed Case 17 (Figure 3) also chose not to do any additional procedure.


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 17 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 52-year-old male suffered a chemical injury in his right eye 5 years earlier. He developed total limbal stem cell deficiency and showed at the initial visit an opaque and vascularized cornea (a) with a conjunctival-like phenotype at in vivo confocal microscopy (IVCM) in central cornea (star), with goblet cells (horizontal arrow), inflammatory cells (vertical arrow), and Langerhans cell (circle), (a1). He received an allogeneic cultivated limbal epithelial transplantation (CLET). (b) After 12 months and although his symptoms and ciliary hyperemia had improved, this case was considered a CLET failure as his epithelial phenotype in central cornea (b1) was still conjunctival-like (star), with inflammatory cells (vertical arrow), evaluated by IVCM.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4588357&req=5

fig3: Case 17 (Table 1) before and after cultivated limbal epithelial transplantation (CLET). This 52-year-old male suffered a chemical injury in his right eye 5 years earlier. He developed total limbal stem cell deficiency and showed at the initial visit an opaque and vascularized cornea (a) with a conjunctival-like phenotype at in vivo confocal microscopy (IVCM) in central cornea (star), with goblet cells (horizontal arrow), inflammatory cells (vertical arrow), and Langerhans cell (circle), (a1). He received an allogeneic cultivated limbal epithelial transplantation (CLET). (b) After 12 months and although his symptoms and ciliary hyperemia had improved, this case was considered a CLET failure as his epithelial phenotype in central cornea (b1) was still conjunctival-like (star), with inflammatory cells (vertical arrow), evaluated by IVCM.
Mentions: Even in the failed Cases 1, 17, and 18, there was subjective improvement as shown by lower OSDI scores and higher NEI-VFQ-25 scores (Table 1). Case 1 had another CLET (Case 16) in which the final outcome was graded as a partial success. This patient elected not to try to rehabilitate his chemically injured right eye any further as he remained mostly asymptomatic, and his left eye had full vision. Failed Case 17 (Figure 3) also chose not to do any additional procedure.

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