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Could Lab-Grown eye cells restore sight? new trial begins

NCT ID NCT03957954

Disease control Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests whether stem cells grown from a patient's own eye can be safely transplanted to repair the cornea in people with limbal stem cell deficiency, a condition that causes vision loss. Twenty adults with severe vision loss will receive the transplant, and researchers will monitor for side effects like infection and check if the cells successfully grow on the eye. The goal is to see if the procedure is safe and feasible before moving to larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main 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. Main 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.

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Conditions

The condition(s) this trial relates to.

limbal stem cell deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Limbal stem cell deficiency

Contacts and locations

Locations

  • University of California

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.