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Stem Cell Therapy for Limbal Stem Cell Deficiency | Clinical Trials | Clareo Health

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Stem Cell Therapy for Limbal Stem Cell Deficiency

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

NCT03957954•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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥18 years of age.
•2. Best corrected visual acuity in the affected eye of 20/160 or less.
•3. Documentation of a LSCD diagnosis and the central cornea is affected.
•4. Absence of lagophthalmos and eyelid abnormality
•5. Adequate forniceal depth is ≥ 5 mm.
•6. LSCD fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit.
•7. If the etiology of LSCD is due to chemical injury, a minimal interval of 1 year since the initial chemical injury is required.
•8. A Schirmer test result at 5 minute of ≥5 mm of wetting.
•9. Absence of active infectious keratitis in either eye at the Enrollment Visit.
•10. Have a life expectancy ≥ 2 years after enrollment.

Exclusion Criteria

•1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
•2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
•3. Exposure keratopathy or lagophthalmos of the study eye.
•4. Persistent severe ocular surface inflammation and/or meibomian gland dysfunction
•5. Chemical injury occurred less than 12 months ago.
•6. Presence of ocular surface tumor.
•7. Uncontrolled diabetes with last hemoglobin A1C (HgA1C) \>8.5.
•8. Presence of known allergies to any of the cLSC components.
•9. Current participation in another simultaneous medical investigation or trial.
•10. Unable to be compliant with or complete the requirements of the study.

Locations (1)

University of California

Los Angeles, California, United States

Key Dates

Start Date

September 30, 2020

Primary Completion Date

February 4, 2027

Completion Date

April 30, 2027

Last Updated

February 10, 2026

Enrollment

ESTIMATED participants

Conditions

Limbal Stem-cell Deficiency

Interventions

cLSC

BIOLOGICAL

Scleral contact lens (SCL)

DEVICE

Treatment of LSCD With DM

NCT05909735

Limbal Stem-cell DeficiencyCongenital Aniridia

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UNKNOWN

The Effects of Allogeneic SLET

NCT04021134

Limbal Stem-cell Deficiency

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UNKNOWN

The Effects of Autologous SLET

NCT04021875

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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