Stem Cell Therapy for Limbal Stem Cell Deficiency

Limbal Stem-cell Deficiency Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency
• Limbal Stem-cell Deficiency

• NCT number: NCT03957954
• Study type: Interventional
• Source: University of California, Los Angeles
• Contact: Clemence Bonnet, MD, PhD
• Phone: 310-825-6232
• Email: CBonnet@mednet.ucla.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: September 30, 2020
• Completion date: May 31, 2024