Stem Cell Therapy for Limbal Stem Cell Deficiency

20 patients with severe to total Limbal Stem Cell Deficiency (LSCD) in one eye attributable to injury or ocular surgery. The first 5 eyes will receive the cLSCs to determine the feasibility and safety. Then the subsequent 15 eyes will be randomized into cLSC group and a scleral lens treatment (SCL) control group in a 2:1 ratio in blocks of 3 or 6 using a random number generator.

Main 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.
• A Schirmer test result at 5 minute of ≥5 mm of wetting.
• Absence of active infectious keratitis in either eye at the Enrollment Visit.
• Have a life expectancy ≥ 2 years after enrollment.

Main 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.
• Current participation in another simultaneous medical investigation or trial.
• Unable to be compliant with or complete the requirements of the study.