NCT03957954

Stem Cell Therapy for Limbal Stem Cell Deficiency

Safety and Feasibility of Cultivated Autologous Limbal Stem Cells (cLSC) for Limbal Stem Cell Deficiency

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Limbal Stem-cell Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	cLSC	Transplantation of cLSC
DEVICE	Scleral contact lens (SCL)	Scleral contact lens device (SCL) will be used to stabilize and improve ocular surface.

Timeline

• Start date: 2020-09-30
• Primary completion: 2027-02-04
• Completion: 2027-04-30
• First posted: 2019-05-21
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study