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Stem cell eye drops aim to heal stubborn corneal defects

NCT ID NCT05727878

Disease control Sponsor: Combangio, Inc 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested an eye drop called KPI-012, made from substances released by stem cells, to see if it could heal persistent corneal epithelial defects (PCED) — wounds on the eye's surface that won't close. The trial enrolled 103 people with PCED from various causes. Participants received either the active drop or a placebo. The main goal was complete healing of the wound. However, the study was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KPI-012 (a solution of proteins and other factors from stem cells)
What this could lead to
If successful, KPI-012 could become a new treatment option for stubborn corneal wounds that don't heal on their own.
What could go wrong
The trial was terminated early, so we have limited data. It's a small Phase 2 study, and the treatment may not prove effective or safe in larger trials.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

103 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Have PCED for at least 7 days prior due to an underlying condition such as diabetic keratopathy, herpetic eye disease, severe dry eye disease, limbal stem cell deficiency, infectious keratitis, neurotrophic keratitis, post ocular surgery, medical trauma, chemical burn, etc. 2. PCED measurements meet study criteria. Exclusion Criteria: 1. Any active ocular infection or any active infectious disease that could impact the PCED. 2. Severe corneal burns in the Study Eye. 3. Severe limbal stem cell deficiency in either eye. 4. The circumference affected by limbal blood vessel ischemia greater than 75% of the circumference in the Study Eye. 5. Severe blepharitis or severe meibomian gland disease. 6. Severe eyelid abnormalities in the Study Eye, contributory to the persistence of the PCED. 7. Evidence of corneal ulceration. 8. Anticipated need for punctal occlusion. 9. Use of Oxervate in the Study Eye within past 30 days. 10. History of any surgical procedure for treatment of the study PCED. 11. History of any other ocular surgery in the Study Eye within 90 days prior to screening. 12. Not willing to suspend use of contact lens in the Study Eye. 13. Any use of Botox injections to induce pharmacologic blepharoptosis in the 90 days. 14. Expected use of systemic doxycycline. 15. Any use of chemotherapeutic agents within 7 days prior to Study, or anticipated use during the study. 16. History of current drug or alcohol abuse or addiction. 17. Use of another investigational agent within 30 days. 18. Participants who are pregnant, breastfeeding, or planning a pregnancy during the study.

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As listed by the trial registrant

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

Persistent corneal epithelial defect

Contacts and locations

Locations

  • Principal Investigator

    Dothan, Alabama, 36301, United States

  • Principal Investigator

    Irvine, California, 92897, United States

  • Principal Investigator

    La Jolla, California, 92037, United States

  • Principal Investigator

    Loma Linda, California, 92354, United States

  • Principal Investigator

    Los Angeles, California, 90013, United States

  • Principal Investigator

    Los Angeles, California, 90095, United States

  • Principal Investigator

    Pasadena, California, 91107, United States

  • Principal Investigator

    Rancho Cordova, California, 95670, United States

  • Principal Investigator

    Aurora, Colorado, 80045, United States

  • Principal Investigator

    Fort Collins, Colorado, 80528, United States

  • Principal Investigator

    Littleton, Colorado, 80120, United States

  • Principal Investigator

    Miami, Florida, 33136, United States

  • Principal Investigator

    Miami, Florida, 33143, United States

  • Principal Investigator

    Orange City, Florida, 32763, United States

  • Principal Investigator

    Atlanta, Georgia, 30339, United States

  • Principal Investigator

    Carmel, Indiana, 46290, United States

  • Principal Investigator

    Indianapolis, Indiana, 46260, United States

  • Principal Investigator

    Louisville, Kentucky, 40206, United States

  • Principal Investigator

    Boston, Massachusetts, 02111, United States

  • Principal Investigator

    Boston, Massachusetts, 02114, United States

  • Principal Investigator

    Chesterfield, Missouri, 63017, United States

  • Principal Investigator

    Kansas City, Missouri, 64111, United States

  • Principal Investigator

    Kansas City, Missouri, 64133, United States

  • Principal Investigator

    St Louis, Missouri, 63131, United States

  • Principal Investigator

    Palisades Park, New Jersey, 07650, United States

  • Principal Investigator

    New York, New York, 10036, United States

  • Principal Investigator

    Rockville Centre, New York, 11570, United States

  • Principal Investigator

    Garner, North Carolina, 27529, United States

  • Principal Investigator

    Powell, Ohio, 43065, United States

  • Principal Investigator

    Philadelphia, Pennsylvania, 19107, United States

  • Principal Investigator

    Pittsburgh, Pennsylvania, 15219, United States

  • Principal Investigator

    Rapid City, South Dakota, 57701, United States

  • Principal Investigator

    Memphis, Tennessee, 38119, United States

  • Principal Investigator

    Nashville, Tennessee, 37215, United States

  • Principal Investigator

    Austin, Texas, 78712, United States

  • Principal Investigator

    Austin, Texas, 78731, United States

  • Principal Investigator

    Houston, Texas, 77030, United States

  • Principal Investigator

    San Antonio, Texas, 78212, United States

  • Principal Investigator

    Norfolk, Virginia, 23502, United States

  • Principal Investigator

    Seattle, Washington, 98119, United States

  • Principal Investigator

    Morgantown, West Virginia, 25606, United States

  • Principal Investigator

    Kenosha, Wisconsin, 53142, United States

  • Principal Investigator

    Caba, Buenos Aires, C1428ARF, Argentina

  • Principal Investigator

    Rosario, Santa Fe Province, S2000, Argentina

  • Principal Investigator

    San Juan, 00921, Puerto Rico

  • Principal investigator

    Durham, North Carolina, 27710, United States

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