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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
CliPS
Seoul, South Korea
Rate of Adverse event
Adverse event
Time frame: From limbal tissue collection until 24 weeks after transplantation
Rate of normal/abnormal results in clinical laboratory test
Comparisons between pre-/post- transplantation are summarized and presented
Time frame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Blood pressure(systolic/diastolic) at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Time frame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Pulse rate at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Time frame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of normal/abnormal results in Electrocardiogram
Comparisons between pre-/post- transplantation are summarized and presented.
Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of normal/abnormal results in physical examination at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of eye infection and inflammation
Eye infection and inflammation test (slit lamp microscopy)
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Time frame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Intraocular pressure test
Intraocular pressure test
Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation