Status:
COMPLETED
Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency
Lead Sponsor:
CliPS Co., Ltd
Conditions:
Limbus Corneae
Limbus Corneae Insufficiency Syndrome
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04773431
Start Date
January 31 2020
End Date
January 14 2021
Last Update
February 26 2021
Active Locations (1)
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1
CliPS
Seoul, South Korea, 04168