Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency

Clinical Study Objective:

To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency

Study Method:

Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. Adverse drug reaction will be confirmed during 24 weeks after transplantation.

Inclusion Criteria:

• Men and women aged 19 or older
• Diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants
• No improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
• BCVA 20/40 or less at screening in the eye with the limbal stem cell deficiency
• Voluntarily agreed to participate in this study and signed a consent form

Exclusion Criteria:

• Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
• Difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
• Severe dry eye with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia < 2 mm/5 min at screening)
• Acute ocular surface inflammation of both corneas at Visit 2
• Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
• Uncontrolled comorbidities such as moderate to severe infections and bleeding
• Positive for virus infection (HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, syphilis)
• Uncontrolled diabetes (HbA1c ≥9.0%)
• Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite taking antihypertensives at screening)
• Uncontrolled glaucoma (IOP > 21 mmHg despite taking glaucoma medication)
• Pregnant or lactating women
• Women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials
• Participation in another clinical study within 4 weeks
• Subjects judged by the investigator to be inappropriate to participate in the clinical study