NCT03302273

Corneal Epithelial Stem Cells and Dry Eye Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Sloan W. Rush, MD · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndromes
• Dry Eye
• Ocular Inflammation
• Ocular Surface Disease
• Ocular Discomfort
• Blepharitis

Interventions

Type	Name	Description
OTHER	Corneal Epithelial Stem Cell Transplant	Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2017-10-05
• Last updated: 2022-04-21

Locations

1 site across 1 country: United States