The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion Criteria:
* Male or female participants age 18 to \<90 years old at time of enrollment
* Ability of a subject or guardian/legal representative to provide written informed consent and to comply with study assessments for the full duration of the study.
* Patients with unilateral limbal stem cell deficiency (LSCD) as determined by conjunctivalization of the cornea defined by fibrovascular pannus more than 2 mm from the limbus for greater than or equal to 6 clock hours.
* Additional optional criteria:
* Lack of limbal palisades of Vogt for greater than or equal to 9 clock hours
* Goblet cell presence as defined by impression cytologic criteria
Exclusion Criteria:
* Corneal or ocular surface infection within 30 days prior to study entry or CALEC transplantation
* Ocular surface malignancy
* Uncontrolled diabetes with most recent HgA1c greater than 8.5%
* Renal Failure with eGFR below 60 mL/min per 1.73 m2
* Aspartate aminotransferase and alanine aminotransferase levels greater than 3 times institutional upper limit of normal
* Total bilirubin greater than 2 times institutional upper limit of normal (except patients with known Gilbert's syndrome)
* Platelet levels less than 100,000 or greater than 450,000 per microliter
* Hemoglobin levels of less than 11.0 g/dL in men or less than 10.0 g/dL in women
* Prothrombin time greater than 16 seconds and activated partial thromboplastin time greater than 35 seconds in patients not taking warfarin and an international nor…