ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation

Study Overview
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Brief Summary
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In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.

Detailed Description
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There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.

Official Title
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ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.

Conditions
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Limbal Stem Cell Deficiency

Intervention / Treatment
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* Procedure: Pannus and conjunctival dissection
* Procedure: Human cultivated limbal stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral limbal stem cell deficiency of any etiology. Corneal impression cytology positive for goblet cells. Ocular ultrasound results within normal parameters. Agree to participate in the study and sign the informed consent. Exclusion Criteria: 1. Active immunological diseases.

Ages Eligible for Study
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Minimum Age: 16 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: Stem Cell Transplantation<br>Cultivated Limbal Stem Cell Transplantation | Procedure: Pannus and conjunctival dissection<br>* A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.<br>Procedure: Human cultivated limbal stem cell transplantation<br>* The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective clinical evaluation | A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization. | 6 months | 
| Objective clinical evaluation | A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal cells morphology | Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology | 6 months | 
| Corneal cells morphology | Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology | 12 months | 
| Quality of life questionnaire | Modified National Eye Institute Visual Function Questionnaire 25 questionnaire | 6 months | 
| Quality of life questionnaire | Modified National Eye Institute Visual Function Questionnaire 25 questionnaire | 12 months | 
| Visual acuity | Visual acuity in the Logarithm of the Minimum Angle of Resolution scale | 6 months | 
| Visual acuity | Visual acuity in the Logarithm of the Minimum Angle of Resolution scale | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cornea, Limbal stem cell