Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

Study Overview
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Brief Summary
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The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.

Official Title
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Advanced Therapy for Ocular Surface Reconstruction. Allogenic Limbus Epithelial Stem-cell Transplant vs Bone Marrow Mesenchymal Stem-cell Transplant in Limbus Insufficiency Syndrome. Double-masked Randomized Trial

Conditions
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Limbus Corneae Insufficiency Syndrome

Intervention / Treatment
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* Procedure: Stem Cell with Amniotic Membrane Transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female older than 18 years. Signed Informed consent Negative pregnancy test at inclusion for any potential childbearing female. Compromise of contraceptive method during all trial for any potential childbearing female. Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology. Availability for all the scheduled visits during the study Exclusion Criteria: Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis. Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end. Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening. Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available. No availability for all scheduled visits during the study. Any other circumstance under investigator´s opinion that prevents patient inclusion even though normal inclusion and exclusion criteria are met.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone Marrow mesenchymal stem cell<br>Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant | Procedure: Stem Cell with Amniotic Membrane Transplant<br>* Single stem cell expansion in amniotic membrane transplant<br>|
| Active Comparator: Allogenic limbal stem cell Transplant<br>Stem Cell with Amniotic Membrane Transplant | Procedure: Stem Cell with Amniotic Membrane Transplant<br>* Single stem cell expansion in amniotic membrane transplant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viability and safety of mesenchymal stem cell transplant | Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of complications in pre and peri surgical implantation | Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification. | 1 Week | 
| Improvement of 2 lines in Best Corrected Visual Acuity | Improvement in visual acuity compared to baseline values before transplant | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limbus, cornea, insufficiency syndrome, stem cell transplant