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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation | Experimental | LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation | Drug | LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse event | Adverse event | From limbal tissue collection until 24 weeks after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of normal/abnormal results in clinical laboratory test | Comparisons between pre-/post- transplantation are summarized and presented | Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation |
| Blood pressure(systolic/diastolic) at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SoHyang Chung, MD,Ph.D | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CliPS | Seoul | 04168 | South Korea |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Comparisons between pre-/post- transplantation are summarized and presented. |
| 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. | 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. | 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. | Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation |
| Rate of eye infection and inflammation | Eye infection and inflammation test (slit lamp microscopy) | Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation |
| Intraocular pressure test | Intraocular pressure test | Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation |