Corneal Epithelial Stem Cells and Dry Eye Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/22/2019 |
| Start Date: | February 1, 2019 |
| End Date: | October 1, 2019 |
| Contact: | Sloan Rush, MD |
| Email: | sunday.fowler@paneye.com |
| Phone: | 806-353-0125 |
Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
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.
(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.
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.
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.
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
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