Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02415218
Eligibility Criteria:
Inclusion Criteria:
* Among patients with bilateral limbal stem-cell deficiency, those who meet all the criteria listed below when they give their informed consent to participate in this research will be included.
1. Patients in whom the eye(s) (subject to the interventional therapy) show(s) loss or dysfunction of corneal epithelial stem cells throughout the total\* circumference of the cornea
2. Patients in whom the corneal surface of the eye(s) (subject to the investigational therapy) is(are) entirely enveloped by conjunctival tissue
3. Patients of both genders aged ≥20 years when they give their informed consent
4. Patients who have given their own written consent to participate in this clinical research (The target disease is bilateral limbal stem-cell deficiency, although it is not always necessary that the both eyes of the patient meet the inclusion criteria.)
Exclusion Criteria:
1. Patients who are or may be pregnant, and patients who are breast feeding
2. Patients with infections (HBV, HCV, HIV, HTLV-1)
3. Patients with extreme hypolacrimation resistant to therapy
4. Patients from whom oral mucosal specimens cannot be collected because clear scar formation or inflammatory findings are noted in a cell-collection site of the mucosal membrane
5. Patients whose score of Performance Status (PS\*) is 3 or more
6. Any others who are judged by the chief subinvestigator to be ineligible for this clinical research, due to the presence of complications, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02415218
Study Brief:
Protocol Section:
NCT02415218