Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.

Detailed Description
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Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.

Official Title
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Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)

Conditions
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Limbal Stem Cell Deficiency

Intervention / Treatment
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* Procedure: Cultured limbal stem cells Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization Presence of Goblet cells on the cornea Minimum tear was about 5 mm Minimum duration of deficiency was 3 years Vision was Light Perception Exclusion Criteria: Systemic disease affecting both eyes such as Stevens-Johnson syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cultured limbal stem cells Transplantation | Procedure: Cultured limbal stem cells Transplantation<br>* Transplantation of cultivated limbal epithelium on amniotic membrane<br>* Other names: Transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Snellen visual acuity |  | 6 months | 
| corneal epithelial integrity and stability |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impression cytology |  | 12 months | 
| Extent of retarding recurrent neovascularisation |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limbal stem cell deficiency