This phase I study will collect preliminary information on the activity and safety of cLSC. We will investigate the ability to manufacture and transplant cLSC onto the cornea successfully at the time of surgery (feasibility), and have cLSC begin to populate the ocular surface (efficacy) without serious adverse events (safety).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female ≥18 years of age.
. Best corrected visual acuity in the affected eye of 20/160 or less.
. Documentation of a LSCD diagnosis and the central cornea is affected.
. Absence of lagophthalmos and eyelid abnormality
. Adequate forniceal depth is ≥ 5 mm.
. LSCD fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit.
. If the etiology of LSCD is due to chemical injury, a minimal interval of 1 year since the initial chemical injury is required.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of cLSC Transplant pertaining to Infection and/or Corneal Perforation
Timeframe: 12 months for all participants
2
Feasibility of cLSC Transplant pertaining to Manufacturing meeting Release Criteria
Timeframe: 12 months for all participants
3
Feasibility of cLSC Transplant pertaining to Manufacturing without Contamination
. A Schirmer test result at 5 minute of ≥5 mm of wetting.
Exclusion criteria
. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
. Exposure keratopathy or lagophthalmos of the study eye.
. Persistent severe ocular surface inflammation and/or meibomian gland dysfunction
. Chemical injury occurred less than 12 months ago.
. Presence of ocular surface tumor.
. Uncontrolled diabetes with last hemoglobin A1C (HgA1C) \>8.5.
. Presence of known allergies to any of the cLSC components.