Corneal Epithelial Stem Cells and Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments. This pilot study will carefully observe and monitor each qualifying and willing individual for response to treatment, signs of toxicity and adverse effects from the treatment, and for ability of the treatment to improve comfort and restore vision.

Detailed Description
-----------------
Eligible patients presenting with severe dry eye disease that have failed treatment with conventional measures will be screened for inclusion into the study. The treatment will consist of administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived product. These eye drops will be transplanted by topical self-administration by the patient four times daily in both eyes for a three month interval.

Official Title
-----------------
Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease

Conditions
-----------------
Dry Eye Syndromes, Dry Eye, Ocular Inflammation, Ocular Surface Disease, Ocular Discomfort, Blepharitis

Intervention / Treatment
-----------------
* Other: Corneal Epithelial Stem Cell Transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of advanced dry eye disease Severe dry eye symptoms despite having tried over a half dozen treatments Exclusion Criteria: Not willing to undergo clinical trial Unable to comply with treatment regimen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corneal Epithelial Stem Cell Transplant<br>The treatment will consist of transplantation (via self-administration) of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material four times daily in both eyes for a three month interval. | Other: Corneal Epithelial Stem Cell Transplant<br>* Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI) | Patient Reported Outcome by Survey | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Snellen | 3 months | 
| Corneal Topography | Automated corneal topographic indices | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cell therapy, dry eye disease