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Stem cell eye drops show promise for Hard-to-Treat corneal damage

NCT ID NCT05204329

Symptom relief Sponsor: University of Illinois at Chicago 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested the safety of eye drops made from stem cell secretions in 9 adults with chronic corneal surface disease that did not improve with standard treatments. The drops were given in increasing doses to find the safest amount. Researchers checked for side effects and measured changes in the cornea's surface and vision over 28 days.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

9 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2024

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.

Inclusion Criteria: * Patients 18 years of age or older * Chronic corneal epithelial disease with fluorescein staining score ≥ 6 by NEI grading scale * Reduced corneal sensation (≤ 4 cm measured by Cochet Bonnet esthesiometry) in at least one corneal quadrant * A stable ocular surface with no objective clinical evidence of significant (\> 50%) improvement/worsening of the epithelial disease in the last 30 days * Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy) Exclusion Criteria: * Any active or suspected ocular infection (bacterial, viral, fungal or protozoal). * Evidence of corneal ulceration with stromal loss \> 10% * Presence of an epithelial defect ≥1.0 mm in the largest diameter in the affected eye * Presence of any size epithelial defect that has been persistent for more than 30 days * Patients unable to discontinue or intermittently remove therapeutic contact lens in the study eye (to apply drops) during the 4-week study period * History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the 3 months prior to study enrollment * History of chemical injury within the last 6 months prior to study enrollment Known hypersensitivity to one of the components of the study or procedural medications (e.g.,fluorescein) * History of drug, medication or alcohol abuse or addiction * Use of any investigational agent within 4 weeks of screening visit * History of previous enrollment in the MSC Secretome Study at a lower dose * Participation in another clinical study at the same time as the present study * Participants who are pregnant at the time of study enrollment

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Conditions

The condition(s) this trial relates to.

corneal disorder corneal ulcer

As listed by the trial registrant

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

CORNEA Corneal defect Corneal epithelium defect Mesenchymal stromal cells

Contacts and locations

Locations

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

More trials for these conditions

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