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Could stem cell eye drops soothe dry eyes?

NCT ID NCT07623382

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests eye drops made from stem cell particles in 20 adults with dry eye disease. Participants use the drops four times daily for four weeks. Researchers track safety and symptom changes like eye staining and tear film stability.

What this could mean

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

Active substance
human umbilical cord mesenchymal stem cell-derived small extracellular vesicle eye drops
What this could lead to
If successful, this could point toward a new way to ease dry eye symptoms using natural cell products.
What could go wrong
This is a very early, small trial with only 20 people. It mainly checks safety, and the drops may not work better than existing treatments.

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

About 20 people

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

Started

Mar 2026

Expected to finish

Nov 2026

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.

Inclusion Criteria: * Subjects who voluntarily participate and sign the informed consent form, are willing to comply with the treatment schedule specified in the study protocol, and attend follow-up visits on time. * Aged ≥ 18 years, with no gender restriction. * Best-corrected visual acuity (BCVA) of both eyes (OU) ≥ 0.1 at the Screening Visit (Visit 1, V1). * History of dry eye disease in both eyes prior to the Screening Visit (Visit 1, V1), with at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, eye fatigue, discomfort, redness, or fluctuating visual acuity. * Meeting one of the following criteria at the Screening Visit (Visit 1, V1): i. Positive corneal fluorescein staining, TBUT \< 10 s, and OSDI score ≥ 13; ii. Negative corneal fluorescein staining, TBUT \< 5 s, and OSDI score ≥ 13 Exclusion Criteria: * Subjects with current ocular herpes or any other ocular infection or inflammation, or a history of ocular herpes or any other ocular infection within 30 days prior to screening. * Subjects with ocular diseases including structural abnormalities of the eyelid margin (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann nodular corneal degeneration, damaged conjunctival goblet cells (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, etc., which, in the investigator's opinion, may increase subject risk or interfere with study outcomes. * Subjects with secondary ocular scarring that, in the investigator's assessment, may affect subject compliance or outcome evaluation (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.). * Subjects with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets all of the following conditions: 1. Not receiving steroids, immunomodulatory, or immunosuppressive agents for the disease; 2. The investigator determines that the medical condition will not impact study results. * Subjects with a history of organ or bone marrow transplantation. * Subjects who wore contact lenses within 30 days prior to screening. * Subjects who received physical therapy for dry eye within 30 days prior to screening, including eyelid scrubbing, meibomian gland expression, warm compresses, fuming, or IPL laser therapy for bilateral dry eye. * Subjects who received oral aspirin or aspirin-containing medications, or used NSAIDs (topical ocular or systemic), or drugs known to induce ocular dryness (e.g., anticholinergics, SSRIs, etc.) within 30 days before dosing, unless the subject has been on a stable dose of such medication for at least 30 days before the baseline visit, with no expected changes during the study. * Subjects who used the following medications within the specified periods before dosing: 1. Antihistamines (ocular or systemic) or any topical ophthalmic medications within 14 days before dosing; 2. Artificial tears within 14 days before dosing; 3. Steroids or mast cell stabilizers (ocular or systemic) within 30 days before dosing; 4. Varenicline or diquafosol within 30 days before dosing; 5. Topical ocular cyclosporine or tacrolimus within 6 weeks before dosing. * Subjects with punctal plugs implantation or a history of punctal cautery within 12 weeks prior to screening. * Subjects who used antiglaucoma medications within 3 months prior to screening, had non-laser glaucoma surgery, or underwent glaucoma laser surgery within 6 months prior to the screening visit. * Subjects who underwent Nd:YAG laser capsulotomy within 6 months prior to screening, or corneal refractive surgery (e.g., LASIK) within 12 months prior to screening. * Subjects with known allergy to fluorescein, multiple drug allergies, or severe allergic diseases. * Subjects with other poorly controlled clinical conditions, such as severe chronic infection, severe cardiopulmonary disease, uncontrolled hypertension (defined as systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive treatment), uncontrolled diabetes mellitus, malignant tumors, etc. * Female subjects with a positive pregnancy test or lactating subjects; female subjects of childbearing potential or male subjects whose partners are of childbearing potential who are unwilling to use contraception during the study and for 1 month after the last dose of study medication. * Subjects who participated in any other clinical trial of investigational drugs or devices within 30 days prior to screening. * Any other conditions deemed by the investigator to make the subject ineligible for enrollment (e.g., depression, etc.).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, China, 361000, China

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