The Marker Expression of Corneal Surface From Penetrating Keratopathy After Collagenase A Assisted COMET Case Series

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04066439
Collaborator
(none)
4
1
12.2
0.3

Study Details

Study Description

Brief Summary

In order to examine the cells of the corneal epithelium in the patients who receive corneal transplantation after collagenase A assisted cultivated oral mucosa epithelium transplant (CA-COMET), we analyzed the specimens from penetrating keratoplasty with immunochemical staining.

Condition or Disease Intervention/Treatment Phase
  • Other: specimen

Detailed Description

Limbal insufficiency may cause persistent corneal erosion, turbidity, and even infection and blindness, leading to major eye damage. In patients with limbal stem cell insufficiency, due to the defect of the limbal stem cells, the new epidermal cells cannot be produced, and without the limbus as a barrier, the cells near the conjunctiva will move toward the center of the cornea, result in replacing the corneal cells and causing corneal conjunctivalization.

In recent years, many surgical methods for treating corneal stem cell defects include amniotic membrane transplantation, autologous limbal cell transplantation, and allogeneic limbal cell transplantation. However, in patients with bilateral total limbal insufficiency, there are no autologous limbal cells in the contralateral eye, and allografts may also have rejection and infection.

Cultured oral mucosa epithelium transplant is a method for treating bilateral full-limbal cell defects. The patient's own oral mucosal cells are cultured in the laboratory, and the cultured epithelium is transplanted to the patient's limbus. In the experiment, mouse cells are used as a feeder cell and transplanted to the human body, which is prone to potential problems such as rejection or infection. In order to resolve these problems, our laboratory modified the process of separating the limbal stem cells. By replacing the dispase II/trypsin-EDTA with Collagenase A, there were no needs to use a feeder cell. This experiment has been successfully completed under the national plan.

In this study, we want to investigate the cells on the ocular surface form the four patients who underwent corneal transplantation after receiving CA-COMET.

Dr.Kuan-Ting Kuo, a pathologist in NTUH, will assist us in the staining of the specimens of the cornea from four patients who underwent corneal transplantation after receiving CA-COMET. The specimens of the four patients will be stained (Immunohistochemistry) with markers of the cornea and conjunctival cells (K3, K4, K12, K13, K19, MUC5, P63).

Study Design

Study Type:
Observational
Anticipated Enrollment :
4 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
The Marker Expression of Corneal Surface From Penetrating Keratopathy After Collagenase A Assisted COMET Case Series
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Aug 6, 2020
Anticipated Study Completion Date :
Aug 6, 2020

Outcome Measures

Primary Outcome Measures

  1. Immunofluorescence staining [1 year]

    Using fluorescence microscope to detect specific biomolecule targets with markers of the cornea and conjunctival cells (K3, K4, K12, K13, K19, MUC5, P63)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The patients who underwent corneal transplantation after receiving CA-COMET in five years.
Exclusion Criteria:
  • The patients who NEVER underwent corneal transplantation after receiving CA-COMET.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei city Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Study Chair: Wei-Li Chen, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT04066439
Other Study ID Numbers:
  • 201905046RINC
First Posted:
Aug 26, 2019
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 28, 2019