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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY021797 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| California Institute for Regenerative Medicine (CIRM) | OTHER |
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This phase I study will collect preliminary information on the activity and safety of cLSC. We will investigate the ability to manufacture and transplant cLSC onto the cornea successfully at the time of surgery (feasibility), and have cLSC begin to populate the ocular surface (efficacy) without serious adverse events (safety).
20 patients with severe to total Limbal Stem Cell Deficiency (LSCD) in one eye attributable to injury or ocular surgery. The first 5 eyes will receive the cLSCs to determine the feasibility and safety. Then the subsequent 15 eyes will be randomized into cLSC group and a scleral lens treatment (SCL) control group in a 2:1 ratio in blocks of 3 or 6 using a random number generator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cultivated Limbal Stem-Cells (cLSC) | Experimental | One dose of cultivated limbal stem-cells (cLSC), size between 7.6 to 15 mm in the average diameter. |
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| Scleral Contact Lens Device (SCL) | Active Comparator | Scleral contact lens device (SCL) will be fitted to stabilize and improve ocular surface. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cLSC | Biological | Transplantation of cLSC |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of cLSC Transplant pertaining to Infection and/or Corneal Perforation | Safety assessed by incidence of Serious Adverse Events (SAEs) directly related to cLSC: infection and/or corneal perforation. | 12 months for all participants |
| Feasibility of cLSC Transplant pertaining to Manufacturing meeting Release Criteria | Feasibility assessed by successful manufacturing of cLSC from biopsy that meets release criteria. | 12 months for all participants |
| Feasibility of cLSC Transplant pertaining to Manufacturing without Contamination | Feasibility assessed by successful cLSC manufacturing without contamination. | 12 months for all participants |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Area of Corneal Epithelial Defect | Evaluate changes in the area of corneal epithelial defect (ED) or lack of ED. | At 6 months and 12 months in both cLSC and the control groups |
| Changes in the Clinical Score |
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Main inclusion Criteria:
Main exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Deng, MD, PhD | Stein Eye Institute UCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| Scleral contact lens (SCL) |
| Device |
Scleral contact lens device (SCL) will be used to stabilize and improve ocular surface. |
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Evaluate changes in the clinical score determined by slit lamp examination using fluorescein staining and confocal imaging.
| At 6 months and 12 months in both cLSC and the control groups |