None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : 1) After a 360-degree conjunctival incision, the conjunctivalized part containing blood vessels on the cornea is peeled off with a blade.
2) The ‘cultured autologous li
Sponsors
CLIPSBnC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 19 or older 2) Patients diagnosed with intractable limbal stem cell deficiency in single eye who have severity in which corneal neovascularization invades more than two quadrants 3) Those who have received previously known treatment(non-surgical/surgical) for intractable limbal stem cell deficiency 6 months prior to screening, but have LSCD Stage IC or higher 4) Those whose best corrected visual acuity of the eye with the limbal stem cell deficiency at screening is 20/40 or less 5) Patients who voluntarily agreed to participate in this clinical trial and signed a consent form
Exclusion criteria
Exclusion criteria: 1) If the donor eye is unsuitable for limbal epithelial cell collection for production of limbal epithelial cell sheet 2) If the eye does not close due to the problem of eyelid function in the limbal stem cell deficiency eye, or if there is an ophthalmic adhesion 3) Severe dry eye patients with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia at screening < 2 mm/5 min) 4) A patient who is deemed impossible to collect limbal epithelial cells or transplant clinical trial drugs due to inflammation in both eyes requiring treatment at visit 2 5) Malignant tumor history(except in case of no recurrence more than 5 years after surgery) 6) Patients with uncontrolled comorbidities such as moderate to severe infections and bleeding 7) Those who test positive for viral infection (HBV, HCV, HIV, CMV, HTLV?/?, syphilis) 8) Patients with uncontrolled diabetes(HbA1c = 9.0%) despite treatment such as oral medications and insulin administration at screening 9) Hypertension patients whose blood pressure is not controlled below SBP 140mmHg or DBP 90mmHg despite taking antihypertensives at screening 10) Uncontrolled glaucoma patients with intraocular pressure(IOP) above 21 mmHg despite taking glaucoma medication 11) Patients who underwent limbal stem cell transplantation or amniotic membrane transplantation within 6 months of screening in the target eye for clinical drug transplantation 12) Patients with immune-mediated keratitis, pterygium(pterygium) or pseudopterygium(pseudopterygium) disease that is not controlled by medical treatment in the target eye for clinical drug transplantation 13) Patients with a history of systemic disease affecting the eye (such as Stevens-Jones syndrome) 14) Pregnant or lactating women 15) Among women of childbearing potential, those who do not agree to use a medically accepted contraceptive method* during the clinical trial period(*hormonal contraception, intrauterine device (IUD (Intrauterine device) or IUS (Intrauterine system)), tubal ligation , double barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges) 16) Those who participated in other clinical trials within 4 weeks of participating in this clinical trial and received investigational drugs or received clinical trial medical devices 17) Patients judged unfit to participate in clinical trials by other investigators
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Corneal examination and eye photography;Eye symptom evaluation;National Eye Institute Visual Functioning Questionnaire 25(NEI-VFQ-25) Questionnaire Evaluation;Maximum corrected visual acuity measurement;Clinical laboratory tests;Physical examination and vital signs;Electrocardiogram;Eye infection and inflammation test;Intraocular pressure test | — |
Primary
| Measure | Time frame |
|---|---|
| Limbal Stem Cell Deficiency(LSCD) Stage assessment;Adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactSoHyang Chung
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed