Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients

Exclusion Criteria

• •1. Bilateral LSCD
• •2. LSCD due to autoimmune disorders and partial LSCD
• •3. Having other ongoing ocular pathologies and acute ocular inflammation
• •4. Previous neoplastic/cancer disease
• •5. Severe dry eyes confirmed by Schirmer's test
• •6. Acute systemic infections
• •7. Prior history of limbal transplantation surgery or multiple surgeries in the limbal region
• •8. Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results.
• •9. Any uncontrolled, inter-current illness that in the opinion of the Investigator may interfere with study evaluation.
• •10. Participants with uncontrolled diabetes will be excluded from the study
• •11. History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization.
• •12. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
• •13. Reproductive age patients not practicing effective and adequate birth control measures
• •14. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.
• •15. Previous participation in this study
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