Corneal Epithelial Stem Cells and Dry Eye Disease

April 20, 2022 updated by: Sloan W. Rush, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Amarillo, Texas, United States, 79109
        • Rush Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corneal Epithelial Stem Cell Transplant
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
Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sloan W. Rush, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

September 30, 2017

First Submitted That Met QC Criteria

October 3, 2017

First Posted (Actual)

October 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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