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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03302273

Enrollment

Registered

2017-10-05

Start date

2019-02-01

Completion date

2022-04-01

Last updated

2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

stem cell therapy, dry eye disease

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.

Interventions

OTHERCorneal Epithelial Stem Cell Transplant

Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Visual Acuity	3 months	Snellen
Corneal Topography	3 months	Automated corneal topographic indices

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026