Limbus Corneae, Limbus Corneae Insufficiency Syndrome
Conditions
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 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.
Interventions
DRUGLSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
Sponsors
CliPS Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse event | From limbal tissue collection until 24 weeks after transplantation | Adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure(systolic/diastolic) at each visit | Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation | Comparisons between pre-/post- transplantation are summarized and presented. |
| Pulse rate at each visit | Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation | Comparisons between pre-/post- transplantation are summarized and presented. |
| Rate of normal/abnormal results in Electrocardiogram | Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation | Comparisons between pre-/post- transplantation are summarized and presented. |
| Rate of normal/abnormal results in clinical laboratory test | Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation | Comparisons between pre-/post- transplantation are summarized and presented |
| Rate of eye infection and inflammation | Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation | Eye infection and inflammation test (slit lamp microscopy) |
| Intraocular pressure test | Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation | Intraocular pressure test |
| Rate of normal/abnormal results in physical examination at each visit | Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation | Comparisons between pre-/post- transplantation are summarized and presented. |
Countries
South Korea
Outcome results
None listed