Stem Cell Therapy for Limbal Stem Cell Deficiency
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- STATUS
- Recruiting
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- End date
- Oct 30, 2023
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- participants needed
- 20
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- sponsor
- University of California, Los Angeles
Summary
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).
Description
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.
Details
| Condition | Limbal Stem-cell Deficiency |
|---|---|
| Treatment | cLSC, Scleral contact lens (SCL) |
| Clinical Study Identifier | NCT03957954 |
| Sponsor | University of California, Los Angeles |
| Last Modified on | 24 February 2022 |
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