Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

• Status: Completed
• Trial end date: 2021-01-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CliPS Co., Ltd

Criteria

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