Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.

Official Title
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Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Conditions
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Limbal Stem Cell Deficiency

Intervention / Treatment
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* Procedure: Cultivated limbal stem cell graft transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation Exclusion Criteria: Subjects who are pregnant or lactating Subjects who have sensitivity to drugs that provide local anesthesia Subjects suffering from active infection of the external eye Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)
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: Limbal Stem Cell Transplant<br>The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea. | Procedure: Cultivated limbal stem cell graft transplantation<br>* A limbal biopsy taken from the contralateral good eye in cases of unilateral disease or from a living related or cadaveric donor in cases of bilateral disease. The limbal stem cells from the biopsy are cultivated until a sheet of cells measuring approximately 12mm in diameter is obtained. This is then ready for transplantation onto the diseased eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | Just before surgery and upto 1 years after surgery | 
| Conjunctivalization |  | Just before surgery and upto 1 years after surgery | 
| Vascularization |  | Just before surgery and upto 1 years after surgery | 
| Epithelialization |  | Just before surgery and upto 1 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged subsequent corneal graft survival time |  | 1 year post corneal transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aniridia,, Steven Johnsons Syndrome,, Ocular burns,, Pterygium