CorneaNCT04066439
The Marker Expression of Corneal Surface From Penetrating Keratopathy After Collagenase A Assisted COMET Case Series
An observational study of Cornea, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cornea
- What is being tested?
- specimen
- How many people
- 4 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 6 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who underwent corneal transplantation after receiving CA-COMET in five years.
Who may be able to join
- The patients who underwent corneal transplantation after receiving CA-COMET in five years.
Who cannot join
- The patients who NEVER underwent corneal transplantation after receiving CA-COMET.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Wei-Li Chen, 02-23123456, chenweili@ntu.edu.tw
About this study
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.
Read the 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).
- Conditions
- Cornea
- Being tested
- specimen
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specimenOther
Immunohistochemistry analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunofluorescence staining
Using fluorescence microscope to detect specific biomolecule targets with markers of the cornea and conjunctival cells (K3, K4, K12, K13, K19, MUC5, P63)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Aug 2019
- Primary completion6 Aug 2020 (estimated)
- Study completion6 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Chen, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066439
- Sponsor's protocol ID
- 201905046RINC
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Marker Expression of Corneal Surface From Penetrating Keratopathy After Collagenase A Assisted COMET Case Series
- ClinicalTrials.gov ID
- NCT04066439
- Acronym / sponsor ID
- 201905046RINC
- Conditions
- Cornea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 6 Aug 2020 (estimated)
- Study completion
- 6 Aug 2020 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who underwent corneal transplantation after receiving CA-COMET in five years.
Key inclusion criteria (1 listed)
- The patients who underwent corneal transplantation after receiving CA-COMET in five years.
Key exclusion criteria (1 listed)
- The patients who NEVER underwent corneal transplantation after receiving CA-COMET.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specimenImmunohistochemistry analysis | Other | – |
Primary outcome
Immunofluorescence staining
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Li Chen study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cornea, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Li Chen (02-23123456 ext. 65168, chenweili@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunofluorescence staining (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.