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 range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Male or female ā„18 years of age.
ā. Best corrected visual acuity in the affected eye of 20/160 or less.
ā. Documentation of a LSCD diagnosis and the central cornea is affected.
ā. Absence of lagophthalmos and eyelid abnormality
ā. Adequate forniceal depth is ā„ 5 mm.
ā. LSCD fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit.
ā. If the etiology of LSCD is due to chemical injury, a minimal interval of 1 year since the initial chemical injury is required.
ā. A Schirmer test result at 5 minute of ā„5 mm of wetting.
Exclusion criteria
ā. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
ā. 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.
ā. Exposure keratopathy or lagophthalmos of the study eye.
ā. Persistent severe ocular surface inflammation and/or meibomian gland dysfunction
ā. Chemical injury occurred less than 12 months ago.
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